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FDA 510(k) Application Details - K090739
Device Classification Name
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510(K) Number
K090739
Device Name
BARD SACROCOLPOPEXY GRAFT
Applicant
C.R. BARD, INC.
8195 INDUSTRIAL BLVD.
COVINGTON, GA 30014 US
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Contact
TERRI MORRIS
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Regulation Number
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Classification Product Code
OTO
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Date Received
03/20/2009
Decision Date
11/10/2009
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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