The following data is part of a premarket notification filed by Surgin Surgical Instrumentation, Inc. with the FDA for Prizm Blade (moria Model) Lsk / Mk8510lsk; Prizm Blade (moria Model) Cb / Mk8511cb.
| Device ID | K011195 |
| 510k Number | K011195 |
| Device Name: | PRIZM BLADE (MORIA MODEL) LSK / MK8510LSK; PRIZM BLADE (MORIA MODEL) CB / MK8511CB |
| Classification | Keratome, Ac-powered |
| Applicant | SURGIN SURGICAL INSTRUMENTATION, INC. 14762 BENTLEY CIRCLE Tustin, CA 92680 |
| Contact | Don Haar |
| Correspondent | Don Haar SURGIN SURGICAL INSTRUMENTATION, INC. 14762 BENTLEY CIRCLE Tustin, CA 92680 |
| Product Code | HNO |
| CFR Regulation Number | 886.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-04-19 |
| Decision Date | 2001-11-06 |