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FDA 510(k) Application Details - K041176
Device Classification Name
More FDA Info for this Device
510(K) Number
K041176
Device Name
URETEX TO TRANS-OBTURATOR URETHRAL SUPPORT SYSTEM
Applicant
SOFRADIM PRODUCTION
5 WHITCOMB AVENUE
AYER, MA 01432 US
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Contact
MARY MCNAMARA-CULLINANE
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Regulation Number
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Classification Product Code
OTN
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Date Received
05/05/2004
Decision Date
05/17/2004
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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