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FDA 510(k) Application Details - K061333
Device Classification Name
Stimulator,Peripheral Nerve,Non-Implanted,For Pelvic Floor Dysfunction
More FDA Info for this Device
510(K) Number
K061333
Device Name
Stimulator,Peripheral Nerve,Non-Implanted,For Pelvic Floor Dysfunction
Applicant
UROPLASTY, INC.
2718 SUMMER ST. NE
MINNEAPOLIS, MN 55413-2820 US
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Contact
LISA GALLATIN
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Regulation Number
876.5310
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Classification Product Code
NAM
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More FDA Info for this Product Code
Date Received
05/12/2006
Decision Date
07/03/2006
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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