The following data is part of a premarket notification filed by Micro Motors, Inc. with the FDA for Electric Surgical Irrigation System - Dual Controller Unit.
| Device ID | K963843 |
| 510k Number | K963843 |
| Device Name: | ELECTRIC SURGICAL IRRIGATION SYSTEM - DUAL CONTROLLER UNIT |
| Classification | Handpiece, Air-powered, Dental |
| Applicant | MICRO MOTORS, INC. 469 ARROYO DR. Encinitas, CA 92024 |
| Contact | Donna L Free |
| Correspondent | Donna L Free MICRO MOTORS, INC. 469 ARROYO DR. Encinitas, CA 92024 |
| Product Code | EFB |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-09-25 |
| Decision Date | 1997-03-31 |