K103047 is an FDA 510(k) clearance for the CERETENE 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 January 5, 2011, 82 days after receiving the submission on October 15, 2010.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.3620.
| 510(k) Number | K103047 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 15, 2010 |
| Decision Date | January 05, 2011 |
| Days to Decision | 82 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 |