The following data is part of a premarket notification filed by Micro Motors, Inc. with the FDA for Dual And Single Irr. Systems Models 29550 & 29555.
Device ID | K904850 |
510k Number | K904850 |
Device Name: | DUAL AND SINGLE IRR. SYSTEMS MODELS 29550 & 29555 |
Classification | Unit, Oral Irrigation |
Applicant | MICRO MOTORS, INC. 151 EAST COLUMBINE AVE. Santa Ana, CA 92707 |
Contact | Russ Reinsch |
Correspondent | Russ Reinsch MICRO MOTORS, INC. 151 EAST COLUMBINE AVE. Santa Ana, CA 92707 |
Product Code | EFS |
CFR Regulation Number | 872.6510 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-10-29 |
Decision Date | 1991-01-25 |