SILK SUTURES
FDA premarket approval N80989/S004 · decided 1988-10-07
Approval details
- PMA number
- N80989
- Supplement
- S004
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SILK SUTURES
- Generic name
- Suture, nonabsorbable, silk
- Applicant
- Lukens Corp.
- Date received
- 1988-05-24
- Decision date
- 1988-10-07
- Days to decision
- 136 days
- Decision code
- APPR
- Product code
- GAP
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Somerville, NJ
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SIXALYZER (K880230) | Lukens Corp. | 1988-03-16 |
| STANFORD STERILE LAP SPONGES (K800102) | Lukens Corp. | 1980-01-28 |
| STANFORD STERILE LAP SPONGES (K792471) | Lukens Corp. | 1979-12-20 |
| LUKENS BONE WAX (GAMMA RADIATION) (K791495) | Lukens Corp. | 1979-09-24 |
| SHAVE PREP SET (K770795) | Lukens Corp. | 1977-07-11 |
| TRAY, CATHETERIZATION W/FOLEY, STERILE (K770797) | Lukens Corp. | 1977-07-11 |
| TRAY, IRRIGATION, STERILE, BASIC (K770799) | Lukens Corp. | 1977-06-22 |
| SKIN SCRUB PREP SET (K770796) | Lukens Corp. | 1977-06-22 |