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FDA 510(k) Application Details - K130843
Device Classification Name
Trocar
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
870.1390
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Classification Product Code
DRC
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More FDA Info for this Product Code
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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