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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Anoscope And Accessories
510(k) Number K133687
Device Name THD N-ANO ANOSCOPE
Applicant
THD SPA
VIA A.ALTOBELLI BONETTI, 3/A
IMOLA, BO,  IT 40026
Applicant Contact GUIDO BONAPACE
Correspondent
THD SPA
VIA A.ALTOBELLI BONETTI, 3/A
IMOLA, BO,  IT 40026
Correspondent Contact GUIDO BONAPACE
Regulation Number876.1500
Classification Product Code
FER  
Subsequent Product Code
GCP  
Date Received12/02/2013
Decision Date 12/11/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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