BIOPURE PORTABLE RO SYSTEM,BIOPURE 4400 SERIES RO SYSTEM, BIOPURE 8400 SERIES RO SYSTEM,BIOPURE WATER PURFICATION PRETRE


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 Number 876.5665
Classification Product Code
FIP  
Date Received 02/03/2003
Decision Date 10/21/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No