The following data is part of a premarket notification filed by Micro Motors, Inc. with the FDA for Dynasurg Dental Irrigation System.
Device ID | K896890 |
510k Number | K896890 |
Device Name: | DYNASURG DENTAL IRRIGATION SYSTEM |
Classification | Unit, Oral Irrigation |
Applicant | MICRO MOTORS, INC. 151 EAST COLUMBINE AVE. Santa Ana, CA 92707 |
Contact | Charles H Newman |
Correspondent | Charles H Newman 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 | 1989-12-08 |
Decision Date | 1990-02-14 |