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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 K834380
Device Name PALL EC PLUS FILTER
Applicant
PALL BIOMEDICAL PRODUCTS CO.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
PALL BIOMEDICAL PRODUCTS CO.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number870.4260
Classification Product Code
DTM  
Date Received12/14/1983
Decision Date 08/03/1984
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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