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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 K070913
Device Name SELF-LIGHT DISPOSABLE ANOSCOPE
Applicant
Sapimed S.P.A.
1676 Village Green Suite A
Crofton,  MD  21114
Applicant Contact E J SMITH
Correspondent
Sapimed S.P.A.
1676 Village Green Suite A
Crofton,  MD  21114
Correspondent Contact E J SMITH
Regulation Number876.1500
Classification Product Code
FER  
Date Received04/02/2007
Decision Date 08/10/2007
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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