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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 K970714
Device Name STRYKER CONSTAVAC BLOOD CONSERVATION SYSTEM II (CBCII)
Original Applicant
STRYKER INSTRUMENTS
4100 east milham ave.
kalamazoo,  MI  49001
Original Contact tammy lounds
Regulation Number868.5830
Classification Product Code
CAC  
Date Received02/27/1997
Decision Date 12/16/1997
Decision substantially equivalent (SE)
Classification Advisory Committee Anesthesiology
Review Advisory Committee Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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