The following data is part of a premarket notification filed by Surgin Surgical Instrumentation, Inc. with the FDA for Accublade (acs Model), Mk8507, Accublade (hansotome Model), Mk8508.
| Device ID | K994015 |
| 510k Number | K994015 |
| Device Name: | ACCUBLADE (ACS MODEL), MK8507, ACCUBLADE (HANSOTOME MODEL), MK8508 |
| Classification | Keratome, Ac-powered |
| Applicant | SURGIN SURGICAL INSTRUMENTATION, INC. 14762 BENTLEY CIRCLE Tustin, CA 92680 |
| Contact | Don Harr |
| Correspondent | Don Harr SURGIN SURGICAL INSTRUMENTATION, INC. 14762 BENTLEY CIRCLE Tustin, CA 92680 |
| Product Code | HNO |
| CFR Regulation Number | 886.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-11-26 |
| Decision Date | 2000-03-15 |