NOVAFIL** AND VASCUFIL** STERILE SYNTHETIC NON-ABSORBABLE SUTURES
FDA 510(k) clearance K990952 · decided 1999-04-01
Clearance details
- K-number
- K990952
- Device name
- NOVAFIL** AND VASCUFIL** STERILE SYNTHETIC NON-ABSORBABLE SUTURES
- Applicant
- United States Surgical, A Division of Tyco Healthc
- Decision
- Substantially Equivalent
- Date received
- 1999-03-22
- Decision date
- 1999-04-01
- Days to decision
- 10 days
- Clearance type
- Traditional
- Product code
- GAT
- Device class
- 2
- Regulation number
- 878.5000
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Norwalk, CT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
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