VACUSOL PLUS DENTAL VACUUM LINE CLEANER/DISINFECTANT

Disinfectant, Medical Devices

BIOTROL, USA, INC.

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.

Pre-market Notification Details

Device IDK934014
510k NumberK934014
Device Name:VACUSOL PLUS DENTAL VACUUM LINE CLEANER/DISINFECTANT
ClassificationDisinfectant, Medical Devices
Applicant BIOTROL, USA, INC. 650 S. TAYLOR AVE. Louisville,  CO  80027
ContactBrahma D Sharma
CorrespondentBrahma D Sharma
BIOTROL, USA, INC. 650 S. TAYLOR AVE. Louisville,  CO  80027
Product CodeLRJ  
CFR Regulation Number880.6890 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-08-17
Decision Date1995-12-06

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