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FDA 510(k) Application Details - K123041
Device Classification Name
Clamp, Vascular
More FDA Info for this Device
510(K) Number
K123041
Device Name
Clamp, Vascular
Applicant
FORGE MEDICAL INC.
150 LEVINBERG LANE
WAYNE, NJ 07470 US
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MASON DIAMOND
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Regulation Number
870.4450
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Classification Product Code
DXC
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More FDA Info for this Product Code
Date Received
09/28/2012
Decision Date
05/29/2013
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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