FDA Registration
Active
🇺🇸 United States
Bovine Pericardial Tissue Patch
Reg #: 3016003911
·
FEI: 3016003911
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- TISGENX, INC.
- Registration Number
- 3016003911
- FEI Number
- 3016003911
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 15615 Alton Pkwy, suite 450
- City
- Irvine
- State
- CA
- ZIP
- 92618
- Country
- US
Regulatory Submissions
- 510(k) Number
- K182493
Owner / Operator
- Firm Name
- TISGENX, INC.
- Operator Number
- 10061291
- Address
- 15615 Alton Pkwy, suite 450
- City
- Irvine
- State
- CA
- Postal Code
- 92618
- Country
- US
- Correspondent
- Kris R Kupumbati
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Mesh, Surgical | FTM | Class 2 | General, Plastic Surgery | No | 2019-10-04 |
Proprietary Names
Bovine Pericardial Tissue Patch
Establishment Types
Manufacture Medical Device