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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 K993738
Device Name DISPOS-A-SCOPE
Applicant
DISPOS-A-SCOPE
315 SKYLINE DR.
LEWISTON,  ID  83501
Applicant Contact LAUREL NICHOLAS
Correspondent
DISPOS-A-SCOPE
315 SKYLINE DR.
LEWISTON,  ID  83501
Correspondent Contact LAUREL NICHOLAS
Regulation Number876.1500
Classification Product Code
FER  
Date Received11/04/1999
Decision Date 01/06/2000
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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