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FDA 510(k) Application Details - K123914
Device Classification Name
More FDA Info for this Device
510(K) Number
K123914
Device Name
RESTORELLE Y CONTOUR
Applicant
COLOPLAST A/S
1601 WEST RIVER ROAD N
MINNEAPOLIS, MN 55411 US
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Contact
TIM CRABTREE
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Regulation Number
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Classification Product Code
OTO
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/19/2012
Decision Date
03/05/2013
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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