The following data is part of a premarket notification filed by Maril Products, Inc. with the FDA for Control Iii Elite.
Device ID | K992661 |
510k Number | K992661 |
Device Name: | CONTROL III ELITE |
Classification | Disinfectant, Medical Devices |
Applicant | MARIL PRODUCTS, INC. 320 WEST 6TH ST. Tustin, CA 92780 |
Contact | Anne R Whitehair |
Correspondent | Anne R Whitehair MARIL PRODUCTS, INC. 320 WEST 6TH ST. Tustin, CA 92780 |
Product Code | LRJ |
CFR Regulation Number | 880.6890 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-08-09 |
Decision Date | 1999-09-14 |