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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name subsystem, water purification
510(k) Number K030348
Device Name BIOPURE PORTABLE RO SYSTEM,BIOPURE 4400 SERIES RO SYSTEM, BIOPURE 8400 SERIES RO SYSTEM,BIOPURE WATER PURFICATION PRETRE
Original Applicant
BIOLAB EQUIPMENT CANADA LTD.
128 grandview ave.
thornhill, ontario,  CA l3t 1h6
Original Contact jerry ponikvar
Regulation Number876.5665
Classification Product Code
FIP  
Date Received02/03/2003
Decision Date 10/21/2003
Decision substantially equivalent (SE)
Classification Advisory Committee Gastroenterology/Urology
Review Advisory Committee Gastroenterology/Urology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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