K081531 is an FDA 510(k) clearance for the AOC SOLUBLE IMPLANT MATERIAL. This device is classified as a Polymer, Ent Synthetic-polyamide (mesh Or Foil Material) (Class II — Special Controls, product code KHJ).
Submitted by Ceremed , Inc. (Los Angeles, US). The FDA issued a Cleared decision on July 18, 2008, 46 days after receiving the submission on June 2, 2008.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.3620.
| 510(k) Number | K081531 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 02, 2008 |
| Decision Date | July 18, 2008 |
| Days to Decision | 46 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
| Product Code | KHJ — Polymer, Ent Synthetic-polyamide (mesh Or Foil Material) |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 874.3620 |