The following data is part of a premarket notification filed by Surgical Instrument Systems (sis), Ltd with the FDA for Advanced Computer Controlled Microkeratome-accm, Model Surgical Instrument Systems (sis).
| Device ID | K993190 |
| 510k Number | K993190 |
| Device Name: | ADVANCED COMPUTER CONTROLLED MICROKERATOME-ACCM, MODEL SURGICAL INSTRUMENT SYSTEMS (SIS) |
| Classification | Keratome, Ac-powered |
| Applicant | SURGICAL INSTRUMENT SYSTEMS (SIS), LTD 18732 SAGINAW Irvine, CA 92612 |
| Contact | Judy Gordon |
| Correspondent | Judy Gordon SURGICAL INSTRUMENT SYSTEMS (SIS), LTD 18732 SAGINAW Irvine, CA 92612 |
| Product Code | HNO |
| CFR Regulation Number | 886.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-09-23 |
| Decision Date | 2000-02-10 |
| Summary: | summary |