K060528 is an FDA 510(k) clearance for the AESCULAP TRELON NONABSORBABLE MULTIFILAMENT POLYAMIDE SURGICAL SUTURE. This device is classified as a Suture, Nonabsorbable, Synthetic, Polyamide (Class II - Special Controls, product code GAR).
Submitted by Aesculap, Inc. (Center Valley, US). The FDA issued a Cleared decision on March 28, 2006, 28 days after receiving the submission on February 28, 2006.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.5020.
| 510(k) Number | K060528 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 28, 2006 |
| Decision Date | March 28, 2006 |
| Days to Decision | 28 days |
| Submission Type | Special |
| 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 |