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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 K853987
Device Name PALL EC PLUS 3LPM MAX. FILTER W/SLEEVE
Applicant
Pall Biomedical Products Co.
77 Crescent Beach Rd.
Glen Cove,  NY  11542
Applicant Contact SIDNEY KRAKAUER
Correspondent
Pall Biomedical Products Co.
77 Crescent Beach Rd.
Glen Cove,  NY  11542
Correspondent Contact SIDNEY KRAKAUER
Regulation Number870.4260
Classification Product Code
DTM  
Date Received09/27/1985
Decision Date 12/11/1985
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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