SILK SURGICAL SUTURES
FDA premarket approval N85143/S007 · decided 1988-07-19
Approval details
- PMA number
- N85143
- Supplement
- S007
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SILK SURGICAL SUTURES
- Generic name
- Suture, nonabsorbable, silk
- Applicant
- Sharpoint, Inc.
- Date received
- 1988-06-21
- Decision date
- 1988-07-19
- Days to decision
- 28 days
- Decision code
- APPR
- Product code
- GAP
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Bethlehem, PA
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| COATED SUTURE NEEDLE (K863595) | Sharpoint, Inc. | 1986-10-24 |
| SURGICAL KNIFE (K861947) | Sharpoint, Inc. | 1986-06-06 |
| EAR KNIVES (K840764) | Sharpoint, Inc. | 1984-05-21 |
| CORNEAL SCLERAL LANCE (K840855) | Sharpoint, Inc. | 1984-05-09 |
| POSTERIOR CAPSULOTOMY CYSTITOME (K840660) | Sharpoint, Inc. | 1984-03-16 |
| ANTERIOR CAPSULECTOMY CYSTITOME (K840659) | Sharpoint, Inc. | 1984-03-16 |
| STAINLESS STEEL SUTURE 316L (K830522) | Sharpoint, Inc. | 1983-03-31 |
| OPHTHALMIC KNIFE (K822112) | Sharpoint, Inc. | 1982-08-10 |