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FDA 510(k) Application Details - K130006
Device Classification Name
More FDA Info for this Device
510(K) Number
K130006
Device Name
BIODESIGN SURGISIS ANTERIOR POSTERIOR PELVIC FLOOR GRAFTS
Applicant
COOK BIOTECH INCORPORATED
1425 INNOVATION PLACE
WEST LAFAYETTE, IN 47906 US
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Contact
NICK X WANG
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Regulation Number
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Classification Product Code
PAI
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Date Received
01/02/2013
Decision Date
04/05/2013
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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