The following data is part of a premarket notification filed by Surgin Surgical Instrumentation, Inc. with the FDA for Surgin Genisis Handpiece.
| Device ID | K954238 |
| 510k Number | K954238 |
| Device Name: | SURGIN GENISIS HANDPIECE |
| Classification | Unit, Phacofragmentation |
| Applicant | SURGIN SURGICAL INSTRUMENTATION, INC. 327 BLACKLEY ST. Temple City, CA 91789 -3139 |
| Contact | Glenn A Dunki-jacobs |
| Correspondent | Glenn A Dunki-jacobs SURGIN SURGICAL INSTRUMENTATION, INC. 327 BLACKLEY ST. Temple City, CA 91789 -3139 |
| 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 | 1995-12-08 |