The following data is part of a premarket notification filed by Innovative Optics, Inc. with the FDA for Innovatome Microkeratome.
| Device ID | K973294 |
| 510k Number | K973294 |
| Device Name: | INNOVATOME MICROKERATOME |
| Classification | Keratome, Ac-powered |
| Applicant | INNOVATIVE OPTICS, INC. 4307 CEDARWOOD DR. Lilburn, GA 30247 |
| Contact | Larry Hicks |
| Correspondent | Larry Hicks INNOVATIVE OPTICS, INC. 4307 CEDARWOOD DR. Lilburn, GA 30247 |
| Product Code | HNO |
| CFR Regulation Number | 886.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-02 |
| Decision Date | 1997-10-03 |
| Summary: | summary |