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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 K080132
Device Name THD DISPOSABLE ANOSCOPE/PROCTOSCOPE
Applicant
THD SPA
VIA CALINDRI 50
S. LAZZARO DI SAVENA, BOLOGNA,  IT 40068
Applicant Contact GUIDO BONAPACE
Correspondent
THD SPA
VIA CALINDRI 50
S. LAZZARO DI SAVENA, BOLOGNA,  IT 40068
Correspondent Contact GUIDO BONAPACE
Regulation Number876.1500
Classification Product Code
FER  
Subsequent Product Code
GCF  
Date Received01/18/2008
Decision Date 04/09/2008
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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