510(k) K011195 ยท HNO Keratome, Ac-Powered
PRIZM BLADE (MORIA MODEL) LSK / MK8510LSK; PRIZM BLADE (MORIA MODEL) CB / MK8511CB
| Applicant | Surgin Surgical Instrumentation, Inc., Tustin CA, US |
| Decision | Substantially Equivalent, Nov 6, 2001 |
| Received | Apr 19, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K011195
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.