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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Microfilter, Blood Transfusion
510(k) Number K873666
Device Name PALL LEUKOCYTE REMOVAL FILTER, BLOOD
Applicant
Pall Biomedical Products Co.
77 Crescent Beach Rd.
Glen Cove,  NY  11542
Applicant Contact SAMUEL T WORTHAM
Correspondent
Pall Biomedical Products Co.
77 Crescent Beach Rd.
Glen Cove,  NY  11542
Correspondent Contact SAMUEL T WORTHAM
Regulation Number880.5440
Classification Product Code
CAK  
Date Received09/10/1987
Decision Date 01/06/1988
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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