The following data is part of a premarket notification filed by Blade Works, Inc. with the FDA for Bladeworks Microkeratome Blade.
| Device ID | K993225 |
| 510k Number | K993225 |
| Device Name: | BLADEWORKS MICROKERATOME BLADE |
| Classification | Keratome, Ac-powered |
| Applicant | BLADE WORKS, INC. 107 SOUTH COVINGTON ST. Hillsboro, TX 76445 |
| Contact | Gary S Mocnik |
| Correspondent | Gary S Mocnik BLADE WORKS, INC. 107 SOUTH COVINGTON ST. Hillsboro, TX 76445 |
| Product Code | HNO |
| CFR Regulation Number | 886.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-09-27 |
| Decision Date | 2000-03-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10850724001602 | K993225 | 000 |
| 10850724001589 | K993225 | 000 |
| 10850724001572 | K993225 | 000 |
| 10850724001565 | K993225 | 000 |
| 10850724001558 | K993225 | 000 |