K003855 is an FDA 510(k) clearance for the HYALOMATRIX CO. This device is classified as a Polymer, Ent Synthetic-polyamide (mesh Or Foil Material) (Class II - Special Controls, product code KHJ).
Submitted by Fidia Advanced Biopolymers Srl (Abano Terme, IT). The FDA issued a Cleared decision on July 3, 2001, 202 days after receiving the submission on December 13, 2000.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.3620.
| 510(k) Number | K003855 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 13, 2000 |
| Decision Date | July 03, 2001 |
| Days to Decision | 202 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 |