FDA 510(k) Application Details - K073260

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

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510(K) Number K073260
Device Name Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Applicant DEVICE PARTNERS INTERNATIONAL
4305 ENTERPRISE DRIVE
SUITE E
WINSTON-SALEM, NC 27106 US
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Contact MONICA E DOUGHERTY
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Regulation Number 870.4290

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Classification Product Code DTL
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Date Received 11/20/2007
Decision Date 03/13/2008
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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