FDA 510(k) Application Details - K953564

Device Classification Name Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

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510(K) Number K953564
Device Name Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Applicant MEDTRONIC CARDIAC SURGERY, MEDTRONIC, INC.
4633 EAST LA PALMA AVE.
ANAHEIM, CA 92807 US
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Contact WAYNE R HOHMAN
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Regulation Number 870.4290

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Classification Product Code DTL
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Date Received 07/31/1995
Decision Date 02/02/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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