The following data is part of a premarket notification filed by Surgistar, Inc. with the FDA for Surgistar Microkeratome Blade, Model No. 2400-lsk.
| Device ID | K030891 |
| 510k Number | K030891 |
| Device Name: | SURGISTAR MICROKERATOME BLADE, MODEL NO. 2400-LSK |
| 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 | 2003-03-21 |
| Decision Date | 2003-06-17 |
| Summary: | summary |