The following data is part of a premarket notification filed by Microspecialties, Inc. with the FDA for Keratome Blade, Chirom Model Alk 500500; Keratome Blade, S.c.m.d. Model Turokeratome 400400.
| Device ID | K980508 |
| 510k Number | K980508 |
| Device Name: | KERATOME BLADE, CHIROM MODEL ALK 500500; KERATOME BLADE, S.C.M.D. MODEL TUROKERATOME 400400 |
| Classification | Keratome, Ac-powered |
| Applicant | MICROSPECIALTIES, INC. 16 HIGGINS DR. Milford, CT 06460 |
| Contact | Charles Vassallo |
| Correspondent | Charles Vassallo MICROSPECIALTIES, INC. 16 HIGGINS DR. 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 | 1998-02-10 |
| Decision Date | 1998-05-01 |
| Summary: | summary |