SUPRAMID EXTRA SUTURES
FDA premarket approval N80838/S016 · decided 1989-10-19
Approval details
- PMA number
- N80838
- Supplement
- S016
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SUPRAMID EXTRA SUTURES
- Generic name
- Suture, nonabsorbable, synthetic, polyamide
- Applicant
- S. Jackson, Inc.
- Date received
- 1989-09-20
- Decision date
- 1989-10-19
- Days to decision
- 29 days
- Decision code
- APPR
- Product code
- GAR
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Alexandria, VA
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SUPRAMESH EXTRA (K080216) | S. Jackson, Inc. | 2008-09-15 |
| STERILE SUPRAFOIL SMOOTH NYLON FOIL SHEETS (K973379) | S. Jackson, Inc. | 1997-09-25 |
| NYLAMID SUTURE (K931612) | S. Jackson, Inc. | 1993-12-17 |
| SUPRAMID SUTURE (K931613) | S. Jackson, Inc. | 1993-12-17 |
| MOPYLEN SUTURE (K931614) | S. Jackson, Inc. | 1993-12-17 |
| MOPYLEN (K922630) | S. Jackson, Inc. | 1992-10-20 |
| N80-838 SUPRAMID EXTRA SUTURE (K912429) | S. Jackson, Inc. | 1991-10-02 |
| SUPRAMID EXTRA SUTURES (K904052) | S. Jackson, Inc. | 1990-10-25 |