POLYVIOLENE SUTURE
FDA premarket approval N80950/S001 · decided 1985-03-22
Approval details
- PMA number
- N80950
- Supplement
- S001
- Trade name
- POLYVIOLENE SUTURE
- Generic name
- Suture, nonabsorbable, synthetic, polyester
- Applicant
- Look, Inc.
- Date received
- 1984-07-10
- Decision date
- 1985-03-22
- Days to decision
- 255 days
- Decision code
- APPR
- Product code
- GAS
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Ada, OK
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| POLYVIOLENE SURGICL SUTURE (K943949) | Look, Inc. | 1994-11-10 |
| LOOK INC. 316L STAINLESS STEEL SURGICAL SUTURE (K933686) | Look, Inc. | 1993-12-23 |
| REVISED LABELING FOR CHROMIC AND PLAIN GUT SUTURES (K926586) | Look, Inc. | 1993-12-22 |
| POLYVIOLENE SUTURE-REVISED LABELING (K926167) | Look, Inc. | 1993-12-17 |
| SILK SUTURES-REVISED LABELING (K926168) | Look, Inc. | 1993-12-17 |
| REVISED LABELING FOR POLYPROPYLENE SUTURE (K926588) | Look, Inc. | 1993-12-17 |
| REVISED LABELING FOR NYLON SUTURE (POLYAMIDE) (K926587) | Look, Inc. | 1993-12-17 |
| LOOK VISCODISSECTOR (K913530) | Look, Inc. | 1991-10-21 |