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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Filter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass
510(k) Number K874405
Device Name PALL STAT PRIME(TM) BLOOD FILTER FOR EXTRA. USE
Applicant
Pall Biomedical Products Co.
77 Crescent Beach Rd.
Glen Cove,  NY  11542
Applicant Contact SAMUEL WORTHAM
Correspondent
Pall Biomedical Products Co.
77 Crescent Beach Rd.
Glen Cove,  NY  11542
Correspondent Contact SAMUEL WORTHAM
Regulation Number870.4270
Classification Product Code
JOD  
Date Received10/28/1987
Decision Date 12/30/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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