Oberheiden P.C.
FDA 510(k) Regulatory Consulting & Legal Support | Oberheiden P.C.
Oberheiden P.C. is a distinguished law firm with extensive expertise in FDA 510(k) regulatory consulting. They provide comprehensive legal and compliance support for medical device companies, guiding them through complex FDA regulatory pathways and ensuring successful 510(k) clearances. Their services are specifically tailored to meet the intricate demands of the 510(k) submission process.
About
Oberheiden P.C. is a distinguished law firm with extensive expertise in FDA 510(k) regulatory consulting. They provide comprehensive legal and compliance support for medical device companies, guiding them through complex FDA regulatory pathways and ensuring successful 510(k) clearances. Their services are specifically tailored to meet the intricate demands of the 510(k) submission process.
Additional information
### **Additional information**
- **Type:** firm
- **Company:** Oberheiden P.C.
- **Years of experience:** 12
- **Location:** United States
- **Availability:** available_now
### **Cruxi analysis**
- **Strength summary:** No information available to assess the consultant's strengths.
- **Unique value:** No information available to determine unique value.
- **Ideal projects:** No information available to determine the ideal project profile.
- **Confidence score:** 10/100
- **Last analyzed:** Sun Dec 14 2025 01:05:47 GMT-0500 (Eastern Standard Time)
### **Qualifications & scope**
- **Submission types:** 510k-traditional
- **Device classes:** class-i, class-ii
- **Specialties:** general-hospital, regulatory strategy
- **Device panels:** general-hospital
- **Regulatory pathways:** 510k
- **Type:** firm
- **Company:** Oberheiden P.C.
- **Years of experience:** 12
- **Location:** United States
- **Availability:** available_now
### **Cruxi analysis**
- **Strength summary:** No information available to assess the consultant's strengths.
- **Unique value:** No information available to determine unique value.
- **Ideal projects:** No information available to determine the ideal project profile.
- **Confidence score:** 10/100
- **Last analyzed:** Sun Dec 14 2025 01:05:47 GMT-0500 (Eastern Standard Time)
### **Qualifications & scope**
- **Submission types:** 510k-traditional
- **Device classes:** class-i, class-ii
- **Specialties:** general-hospital, regulatory strategy
- **Device panels:** general-hospital
- **Regulatory pathways:** 510k
Key Highlights
- No information available to assess the consultant's strengths.
- No information available to determine unique value.
Certifications & Trust Signals
- 12 years experience
Buyer Snapshot
Best for
- No information available to determine the ideal project profile.
HQ:
Dallas, United States
Languages:
English
Timezones:
UTC-6, UTC-5
Claim status:
Listed
Services & Capabilities
FDA 510(k) Submission Services
Jurisdictions:
US
Services Offered:
510(k) Strategy & Authoring, Traditional 510(k) Support, Special 510(k) Support, Abbreviated 510(k) Support, Predicate Research & Substantial Equivalence Strategy, De Novo Strategy & Authoring, PMA Strategy & Support, Pre-Sub / Q-Sub Preparation, FDA Meeting Support (Q-Sub / Type C), Labeling Review for Submission (510(k)/De Novo/PMA), Submission Project Management (end-to-end)
Pathways Supported:
Traditional 510(k), Special 510(k), Abbreviated 510(k), De Novo, PMA, Pre-Sub / Q-Sub
Device Types Supported:
Medical device
Supports Predicate Research:
Yes
Years Experience:
14
Ex FDA:
Yes
Ex Notified Body:
No
Ex Big Medtech:
No
Device Panels:
general-hospital
Engagement Models:
Project-based, Retainer
Accepting New Clients:
Yes
Supports Estar:
No
Supports Rta Remediation:
Yes
Supports Labeling Review:
Yes
Provides Submission Project Management:
Yes
