The following data is part of a premarket notification filed by Micro Motors, Inc. with the FDA for Handpiece System With Motor (several Models).
Device ID | K896878 |
510k Number | K896878 |
Device Name: | HANDPIECE SYSTEM WITH MOTOR (SEVERAL MODELS) |
Classification | Handpiece, Air-powered, Dental |
Applicant | MICRO MOTORS, INC. 26941 CABOT RD. SUITE 128 Laguna Hills, CA 92653 |
Contact | Charles H Newman |
Correspondent | Charles H Newman MICRO MOTORS, INC. 26941 CABOT RD. SUITE 128 Laguna Hills, CA 92653 |
Product Code | EFB |
CFR Regulation Number | 872.4200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-12-08 |
Decision Date | 1990-03-08 |