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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 K833048
Device Name PURGES LINES, PL-45 & PL-33
Applicant
American Bentley
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
American Bentley
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number870.4260
Classification Product Code
DTM  
Date Received09/06/1983
Decision Date 10/20/1983
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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