K981582 is an FDA 510(k) clearance for the SURGILON, DERMALON, & OPHTHALON. This device is classified as a Suture, Nonabsorbable, Synthetic, Polyamide (Class II - Special Controls, product code GAR).
Submitted by Davis & Geck, Inc. (Hazlewood, US). The FDA issued a Cleared decision on July 13, 1998, 70 days after receiving the submission on May 4, 1998.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.5020.
| 510(k) Number | K981582 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 04, 1998 |
| Decision Date | July 13, 1998 |
| Days to Decision | 70 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | GAR — Suture, Nonabsorbable, Synthetic, Polyamide |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.5020 |