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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, Cardiopulmonary Bypass, Arterial Line
510(k) Number K902518
Device Name LD-SIX ARTERIAL BLOOD FILTER FOR EXTRA. SERVICE
Applicant
Pall Biomedical Products Co.
77 Crescent Beach Rd.
Glen Cove,  NY  11542
Applicant Contact A DICKSTEIN
Correspondent
Pall Biomedical Products Co.
77 Crescent Beach Rd.
Glen Cove,  NY  11542
Correspondent Contact A DICKSTEIN
Regulation Number870.4260
Classification Product Code
DTM  
Date Received06/06/1990
Decision Date 10/16/1990
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
Recalls CDRH Recalls
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