K003015 is an FDA 510(k) clearance for the SSC'S PCL MONOFILAMENT SAS, VIOLET, COATED, MODEL TBD. This device is classified as a Suture, Absorbable, Synthetic (Class II - Special Controls, product code GAN).
Submitted by Surgical Specialties Corp (Reading, US). The FDA issued a Cleared decision on December 15, 2000, 79 days after receiving the submission on September 27, 2000.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4830.
| 510(k) Number | K003015 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 27, 2000 |
| Decision Date | December 15, 2000 |
| Days to Decision | 79 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | GAN — Suture, Absorbable, Synthetic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4830 |