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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name ligator, hemorrhoidal
510(k) Number K093497
Device Name THD BANDY
Applicant
THD SPA
VIA BORGO SANTA CRISTINA 12
IMOLA, BO,  IT 40026
Applicant Contact GUIDO BONAPACE
Correspondent
THD SPA
VIA BORGO SANTA CRISTINA 12
IMOLA, BO,  IT 40026
Correspondent Contact GUIDO BONAPACE
Regulation Number876.4400
Classification Product Code
FHN  
Date Received11/12/2009
Decision Date 07/15/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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