The following data is part of a premarket notification filed by Med-logics, Inc. with the FDA for Ml Microkeratome Blade.
| Device ID | K962661 |
| 510k Number | K962661 |
| Device Name: | ML MICROKERATOME BLADE |
| Classification | Keratome, Ac-powered |
| Applicant | MED-LOGICS, INC. 9327 BLACKLEY ST. Temple City, CA 91780 |
| Contact | Glenn A Dunkin-jacobs |
| Correspondent | Glenn A Dunkin-jacobs MED-LOGICS, INC. 9327 BLACKLEY ST. Temple City, CA 91780 |
| Product Code | HNO |
| CFR Regulation Number | 886.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-07-08 |
| Decision Date | 1996-12-09 |