The following data is part of a premarket notification filed by Hawken Industries with the FDA for Flapmaker Disposable Microkeratome.
| Device ID | K981155 |
| 510k Number | K981155 |
| Device Name: | FLAPMAKER DISPOSABLE MICROKERATOME |
| Classification | Keratome, Ac-powered |
| Applicant | HAWKEN INDUSTRIES 26650 RENAISSANCE PKWY., STE.3 Cleveland, OH 44128 |
| Contact | Ge0rge Myers |
| Correspondent | Ge0rge Myers HAWKEN INDUSTRIES 26650 RENAISSANCE PKWY., STE.3 Cleveland, OH 44128 |
| Product Code | HNO |
| CFR Regulation Number | 886.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-03-31 |
| Decision Date | 1998-08-14 |
| Summary: | summary |