The following data is part of a premarket notification filed by Microsurge, Inc. with the FDA for Microsurge Suction/irrigation System.
| Device ID | K925830 |
| 510k Number | K925830 |
| Device Name: | MICROSURGE SUCTION/IRRIGATION SYSTEM |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | MICROSURGE, INC. 45 WEST ST. SUITE 2 Attleboro, MA 02703 |
| Contact | Mary M Mcnamara |
| Correspondent | Mary M Mcnamara MICROSURGE, INC. 45 WEST ST. SUITE 2 Attleboro, MA 02703 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-11-17 |
| Decision Date | 1993-05-17 |