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FDA 510(k) Application Details - K091152
Device Classification Name
More FDA Info for this Device
510(K) Number
K091152
Device Name
VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM, MODEL 50020
Applicant
COLOPLAST A/S
HOLTEDAM 1
HUMLEBAEK 3050 DK
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Contact
ANGELA BYLAND
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Regulation Number
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Classification Product Code
OTM
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Date Received
04/20/2009
Decision Date
05/07/2009
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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