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 |