The following data is part of a premarket notification filed by Micro Motors, Inc. with the FDA for Micro Rsh High Speed Handpiece.
Device ID | K935676 |
510k Number | K935676 |
Device Name: | MICRO RSH HIGH SPEED HANDPIECE |
Classification | Handpiece, Air-powered, Dental |
Applicant | MICRO MOTORS, INC. 151 EAST COLUMBINE AVE. Santa Ana, CA 92707 |
Contact | Ronald G Coss |
Correspondent | Ronald G Coss MICRO MOTORS, INC. 151 EAST COLUMBINE AVE. Santa Ana, CA 92707 |
Product Code | EFB |
CFR Regulation Number | 872.4200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-11-26 |
Decision Date | 1995-03-31 |