The following data is part of a premarket notification filed by Biotrol, Usa, Inc. with the FDA for Vacusol Plus Dental Vacuum Line Cleaner/disinfectant.
Device ID | K934014 |
510k Number | K934014 |
Device Name: | VACUSOL PLUS DENTAL VACUUM LINE CLEANER/DISINFECTANT |
Classification | Disinfectant, Medical Devices |
Applicant | BIOTROL, USA, INC. 650 S. TAYLOR AVE. Louisville, CO 80027 |
Contact | Brahma D Sharma |
Correspondent | Brahma D Sharma BIOTROL, USA, INC. 650 S. TAYLOR AVE. Louisville, CO 80027 |
Product Code | LRJ |
CFR Regulation Number | 880.6890 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-08-17 |
Decision Date | 1995-12-06 |