FDA Registration
Active
🇺🇸 United States
GORE® BIO-A® Tissue Reinforcement
Reg #: 3003910212
·
FEI: 3003910212
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- W. L. GORE & ASSOCIATES, INC.
- Registration Number
- 3003910212
- FEI Number
- 3003910212
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 301 AIRPORT RD.
- City
- ELKTON
- State
- MD
- ZIP
- 21921
- Country
- US
Regulatory Submissions
- 510(k) Number
- K191773
Owner / Operator
- Firm Name
- W. L. GORE & ASSOCIATES, INC.
- Operator Number
- 9925013
- Address
- 1505 North Fourth Street
- City
- Flagstaff
- State
- AZ
- Postal Code
- 86004
- Country
- US
- Correspondent
- Lisa Wells
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Mesh, Surgical, Absorbable, Thoracic, Chest Wall Reconstruction | OWZ | Class 2 | General, Plastic Surgery | No | 2019-08-01 |
| Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery | OXF | Class 2 | General, Plastic Surgery | No | 2019-08-01 |
| Mesh, Surgical, Absorbable, Staple Line Reinforcement | OXC | Class 2 | General, Plastic Surgery | No | 2019-08-01 |
| Mesh, Surgical, Absorbable, Abdominal Hernia | OWT | Class 2 | General, Plastic Surgery | No | 2019-08-01 |
Proprietary Names
GORE® BIO-A® Tissue Reinforcement
Establishment Types
Manufacture Medical Device