The following data is part of a premarket notification filed by Micro Motors, Inc. with the FDA for Sterile Water Pump.
Device ID | K970002 |
510k Number | K970002 |
Device Name: | STERILE WATER PUMP |
Classification | Unit, Operative Dental |
Applicant | MICRO MOTORS, INC. 151 EAST COLUMBINE AVE. Santa Ana, CA 92707 |
Contact | Charles E Strait |
Correspondent | Charles E Strait MICRO MOTORS, INC. 151 EAST COLUMBINE AVE. Santa Ana, CA 92707 |
Product Code | EIA |
CFR Regulation Number | 872.6640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-01-02 |
Decision Date | 1997-03-05 |