FDA 510(k) Application Details - K080169

Device Classification Name Clamp, Vascular

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510(K) Number K080169
Device Name Clamp, Vascular
Applicant GUIDANT CORPORATION, CARDIAC SURGERY
170 BAYTECH DRIVE
SAN JOSE, CA 95134 US
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Contact ELIZABETH TRUJILLO
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Regulation Number 870.4450

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Classification Product Code DXC
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Date Received 01/24/2008
Decision Date 02/08/2008
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 Y
Expedited Review



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