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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name apparatus, autotransfusion
510(k) Number K012406
Device Name ACCESS SEQUESTRATION SYSTEM
Original Applicant
INTERPORE CROSS INTL.
181 technology dr.
irvine,  CA  92618 -2402
Original Contact proise rey-fessler
Regulation Number868.5830
Classification Product Code
CAC  
Date Received07/30/2001
Decision Date 03/26/2002
Decision substantially equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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