K010852 is an FDA 510(k) clearance for the OSMED TISSUE EXPANDER. This device is classified as a Expander, Tissue, Orbital (Class II - Special Controls, product code NFM).
Submitted by Iop, Inc. (Costa Mesa, US). The FDA issued a Cleared decision on August 13, 2001, 145 days after receiving the submission on March 21, 2001.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.3320.
| 510(k) Number | K010852 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 21, 2001 |
| Decision Date | August 13, 2001 |
| Days to Decision | 145 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Statement |
| Product Code | NFM — Expander, Tissue, Orbital |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.3320 |