The following data is part of a premarket notification filed by Micro Specialties, Inc. with the FDA for M2 Compatible Microkeratome Blade.
| Device ID | K033457 |
| 510k Number | K033457 |
| Device Name: | M2 COMPATIBLE MICROKERATOME BLADE |
| Classification | Keratome, Ac-powered |
| Applicant | MICRO SPECIALTIES, INC. 264 QUARRY ROAD Milford, CT 06460 |
| Contact | Leigh S Ayres |
| Correspondent | Leigh S Ayres MICRO SPECIALTIES, INC. 264 QUARRY ROAD Milford, CT 06460 |
| Product Code | HNO |
| CFR Regulation Number | 886.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-10-30 |
| Decision Date | 2004-05-25 |
| Summary: | summary |