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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 K862068
Device Name GELMAN ARTERIAL FILTER (43, 33 AND 21 MICRON)
Applicant
Gelman Sciences, Inc.
600 S. Wagner Rd.
Ann Arbor,  MI  48103 -9019
Applicant Contact HARWOOD GREEN
Correspondent
Gelman Sciences, Inc.
600 S. Wagner Rd.
Ann Arbor,  MI  48103 -9019
Correspondent Contact HARWOOD GREEN
Regulation Number870.4260
Classification Product Code
DTM  
Date Received05/30/1986
Decision Date 08/08/1986
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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