The following data is part of a premarket notification filed by Surgistar, Inc. with the FDA for Ricrokeratome Blade.
| Device ID | K992978 |
| 510k Number | K992978 |
| Device Name: | RICROKERATOME BLADE |
| Classification | Keratome, Ac-powered |
| Applicant | SURGISTAR, INC. 6068 CORTE DEL CEDRO Carlsbad, CA 92009 |
| Contact | Jonathan Woodward |
| Correspondent | Jonathan Woodward SURGISTAR, INC. 6068 CORTE DEL CEDRO Carlsbad, CA 92009 |
| Product Code | HNO |
| CFR Regulation Number | 886.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-09-03 |
| Decision Date | 1999-11-16 |
| Summary: | summary |