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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 K121135
Device Name THD ANOSCOPE, PROCTOSCOPE, RECTOSCOPE, RECTOSCOPE AND LIGHT-SCOPE
Applicant
THD SPA
via borgo santa cristina 12
imola,  IT 40026
Applicant Contact guido bonapace
Correspondent
THD SPA
via borgo santa cristina 12
imola,  IT 40026
Correspondent Contact guido bonapace
Regulation Number876.1500
Classification Product Code
FER  
Subsequent Product Code
GCP  
Date Received04/13/2012
Decision Date 06/01/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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