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FDA 510(k) Application Details - K063136
Device Classification Name
More FDA Info for this Device
510(K) Number
K063136
Device Name
NEEDLELESS SLING
Applicant
SPECIALITIES REMEEX INTERNATIONAL, S.L.
7307 GLOUCHESTER DRIVE
EDINA, MN 55435 US
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Contact
JEFFREY R SHIDEMAN
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Regulation Number
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Classification Product Code
PAH
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Date Received
10/16/2006
Decision Date
12/19/2006
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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