The following data is part of a premarket notification filed by Surgeon Surgical Instrumentation, Inc. with the FDA for Surgin Genisis Phacoemulsifier.
| Device ID | K954241 |
| 510k Number | K954241 |
| Device Name: | SURGIN GENISIS PHACOEMULSIFIER |
| Classification | Unit, Phacofragmentation |
| Applicant | SURGEON SURGICAL INSTRUMENTATION, INC. 9327 BLACKLEY ST. Temple City, CA 91780 |
| Contact | Glenn Dunki-jacobs |
| Correspondent | Glenn Dunki-jacobs SURGEON SURGICAL INSTRUMENTATION, INC. 9327 BLACKLEY ST. Temple City, CA 91780 |
| Product Code | HQC |
| CFR Regulation Number | 886.4670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-11 |
| Decision Date | 1995-12-01 |