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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name oxygenator, cardiopulmonary bypass
510(k) Number K901249
Device Name PLEXUS 3.5(TM) PEDIATRIC HOLLOW FIBER OXYGENATOR
Applicant
SHILEY, INC.
17600 GILLETTE AVE.
P.O. BOX 19503
IRVINE,  CA  92714
Applicant Contact ABATI, PHD
Correspondent
SHILEY, INC.
17600 GILLETTE AVE.
P.O. BOX 19503
IRVINE,  CA  92714
Correspondent Contact ABATI, PHD
Regulation Number870.4350
Classification Product Code
DTZ  
Date Received03/16/1990
Decision Date 06/11/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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