The following data is part of a premarket notification filed by Blade Works, Inc. with the FDA for Bladeworks Microkeratome Blade, Model 7061.
| Device ID | K020079 |
| 510k Number | K020079 |
| Device Name: | BLADEWORKS MICROKERATOME BLADE, MODEL 7061 |
| Classification | Keratome, Ac-powered |
| Applicant | BLADE WORKS, INC. 1816 TOWHEE ST. San Marcos, CA 92069 |
| Contact | Mark Moyer |
| Correspondent | Mark Moyer BLADE WORKS, INC. 1816 TOWHEE ST. San Marcos, CA 92069 |
| Product Code | HNO |
| CFR Regulation Number | 886.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-01-10 |
| Decision Date | 2002-04-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10850724001367 | K020079 | 000 |
| 10850724001275 | K020079 | 000 |
| 10850724001268 | K020079 | 000 |
| 10850724001176 | K020079 | 000 |
| 10850724001169 | K020079 | 000 |
| 10850724001077 | K020079 | 000 |