K033182 is an FDA 510(k) clearance for the PRIZM KERATOME BLADE (B.D. MODEL), MODEL MK8530BD. This device is classified as a Keratome, Ac-powered (Class I - General Controls, product code HNO).
Submitted by Surgin Surgical Instrumentation, Inc. (Tustin, US). The FDA issued a Cleared decision on January 30, 2004, 121 days after receiving the submission on October 1, 2003.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4370.
| 510(k) Number | K033182 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 01, 2003 |
| Decision Date | January 30, 2004 |
| Days to Decision | 121 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Statement |
| Product Code | HNO — Keratome, Ac-powered |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 886.4370 |