FDA Registration
Active
🇺🇸 United States
TIGR Matrix Surgical Mesh
Reg #: 3009514842
·
FEI: 3009514842
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- NOVUS SCIENTIFIC INC
- Registration Number
- 3009514842
- FEI Number
- 3009514842
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 190 Industrial Road, Suite 2
- City
- Wrentham
- State
- MA
- ZIP
- 02093
- Country
- US
Regulatory Submissions
- 510(k) Number
- K191749
Owner / Operator
- Firm Name
- Novus Scientific Inc
- Operator Number
- 10046437
- Address
- Virdings Alle 2
- City
- Uppsala
- State
- SE-C
- Postal Code
- 75450
- Country
- SE
- Correspondent
- malin Kylberg
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Surgical Film | OOD | Class 2 | General, Plastic Surgery | No | 2021-02-25 |
| Mesh, Surgical, Absorbable, Abdominal Hernia | OWT | Class 2 | General, Plastic Surgery | No | 2021-02-25 |
| Mesh, Surgical, Polymeric | FTL | Class 2 | General, Plastic Surgery | No | 2021-02-25 |
Proprietary Names
TIGR Matrix Surgical Mesh
Establishment Types
Complaint File Establishment per 21 CFR 820.198