The following data is part of a premarket notification filed by Surgin Surgical Instrumentation, Inc. with the FDA for Irrigation/bipolar Set.
| Device ID | K942944 |
| 510k Number | K942944 |
| Device Name: | IRRIGATION/BIPOLAR SET |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | SURGIN SURGICAL INSTRUMENTATION, INC. 14762 BENTLEY CIRCLE Tustin, CA 92680 |
| Contact | Don W Harr |
| Correspondent | Don W Harr SURGIN SURGICAL INSTRUMENTATION, INC. 14762 BENTLEY CIRCLE Tustin, CA 92680 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-22 |
| Decision Date | 1994-09-27 |