The following data is part of a premarket notification filed by Microspecialties, Inc. with the FDA for Keratome Blade (135 Micron, Model 300135), (160 Micron, Model 300160), (200 Micron, Model 30020).
| Device ID | K980510 |
| 510k Number | K980510 |
| Device Name: | KERATOME BLADE (135 MICRON, MODEL 300135), (160 MICRON, MODEL 300160), (200 MICRON, MODEL 30020) |
| 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 |