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FDA 510(k) Application Details - K103647
Device Classification Name
Anoscope And Accessories
More FDA Info for this Device
510(K) Number
K103647
Device Name
Anoscope And Accessories
Applicant
THD SPA
VIA BORGO SANTA CRISTINA 12
IMOLA, BO 40026 IT
Other 510(k) Applications for this Company
Contact
GUIDO BONAPACE
Other 510(k) Applications for this Contact
Regulation Number
876.1500
More FDA Info for this Regulation Number
Classification Product Code
FER
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/13/2010
Decision Date
03/01/2011
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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