FDA 510(k) Application Details - K130843

Device Classification Name Trocar

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510(K) Number K130843
Device Name Trocar
Applicant Oscor Inc.
3816 DeSoto Blvd
Palm Harbor, FL 34683 US
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Contact MILA DOSKOCIL
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Regulation Number 870.1390

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Classification Product Code DRC
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Date Received 03/27/2013
Decision Date 01/08/2014
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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