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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Protector, Transducer, Dialysis
510(k) Number K862015
Device Name O.2 MICRON INFECTION RESISTANT HYDROPHOBIC FILTER
Applicant
Bipore, Inc.
16 Edward St.
Demarest,  NJ  07627
Applicant Contact ELIZABETH KOCH
Correspondent
Bipore, Inc.
16 Edward St.
Demarest,  NJ  07627
Correspondent Contact ELIZABETH KOCH
Regulation Number876.5820
Classification Product Code
FIB  
Date Received05/28/1986
Decision Date 07/22/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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