K982646 is an FDA 510(k) clearance for the AILEE SUTURES AND AILEE NEEDLES. This device is classified as a Suture, Absorbable, Natural (Class II - Special Controls, product code GAL).
Submitted by Myco Medical Supplies, Inc. (Cary, US). The FDA issued a Cleared decision on June 2, 1999, 308 days after receiving the submission on July 29, 1998.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4830.
| 510(k) Number | K982646 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 29, 1998 |
| Decision Date | June 02, 1999 |
| Days to Decision | 308 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | GAL - Suture, Absorbable, Natural |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4830 |