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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 K103647
Device Name THD DISPOSABLE ANOSCOPES, PROCTOSCOPES AND RECTOSCOPES
Applicant
Thd Spa
Via Borgo Santa Cristina 12
Imoa,  IT 40026
Applicant Contact GUIDO BONAPACE
Correspondent
Thd Spa
Via Borgo Santa Cristina 12
Imoa,  IT 40026
Correspondent Contact GUIDO BONAPACE
Regulation Number876.1500
Classification Product Code
FER  
Date Received12/13/2010
Decision Date 03/01/2011
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
Predetermined Change
Control Plan Authorized		 No
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