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FDA 510(k) Application Details - K093497
Device Classification Name
Ligator, Hemorrhoidal
More FDA Info for this Device
510(K) Number
K093497
Device Name
Ligator, Hemorrhoidal
Applicant
THD SPA
VIA BORGO SANTA CRISTINA 12
IMOLA, BO 40026 IT
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Contact
GUIDO BONAPACE
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Regulation Number
876.4400
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Classification Product Code
FHN
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More FDA Info for this Product Code
Date Received
11/12/2009
Decision Date
07/15/2010
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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