K771726 is an FDA 510(k) clearance for the BIOSPONGE STAPES PISTON. This device is classified as a Polymer, Ent Synthetic, Porous Polyethylene (Class II - Special Controls, product code JOF).
Submitted by Xomed, Inc. (Arnold, US). The FDA issued a Cleared decision on September 26, 1977, 13 days after receiving the submission on September 13, 1977.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.3620.
| 510(k) Number | K771726 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 13, 1977 |
| Decision Date | September 26, 1977 |
| Days to Decision | 13 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | — |
| Product Code | JOF — Polymer, Ent Synthetic, Porous Polyethylene |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.3620 |