K091240 is an FDA 510(k) clearance for the ALPHAMED SURGICAL SPEAR, MODEL 70-5000. This device is classified as a Sponge, Ophthalmic (Class II - Special Controls, product code HOZ).
Submitted by Alphamed, Inc. (El Paso, US). The FDA issued a Cleared decision on October 23, 2009, 179 days after receiving the submission on April 27, 2009.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4790.
| 510(k) Number | K091240 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 27, 2009 |
| Decision Date | October 23, 2009 |
| Days to Decision | 179 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Statement |
| Product Code | HOZ - Sponge, Ophthalmic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.4790 |