The following data is part of a premarket notification filed by Micro Motors, Inc. with the FDA for Micro Ics Sonic Scaler.
Device ID | K942380 |
510k Number | K942380 |
Device Name: | MICRO ICS SONIC SCALER |
Classification | Scaler, Ultrasonic |
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 | ELC |
CFR Regulation Number | 872.4850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-05-19 |
Decision Date | 1995-08-07 |