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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Disinfectant, Medical Devices
510(k) Number K934014
Device Name VACUSOL PLUS DENTAL VACUUM LINE CLEANER/DISINFECTANT
Applicant
Biotrol, USA, Inc.
650 S. Taylor Ave.
Louisville,  CO  80027
Applicant Contact BRAHMA D SHARMA
Correspondent
Biotrol, USA, Inc.
650 S. Taylor Ave.
Louisville,  CO  80027
Correspondent Contact BRAHMA D SHARMA
Regulation Number880.6890
Classification Product Code
LRJ  
Date Received08/17/1993
Decision Date 12/06/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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