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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name lamp, endoscope, incandescent
510(k) Number K971455
Device Name CLARUS MODEL 5197 SIGHTLITE
Applicant
CLARUS MEDICAL SYSTEMS, INC.
1000 BOONE AVENUE NORTH
#100
MINNEAPOLIS,  MN  55427 -8656
Applicant Contact DALE SAPPENFIELD
Correspondent
CLARUS MEDICAL SYSTEMS, INC.
1000 BOONE AVENUE NORTH
#100
MINNEAPOLIS,  MN  55427 -8656
Correspondent Contact DALE SAPPENFIELD
Regulation Number876.1500
Classification Product Code
FTI  
Date Received04/21/1997
Decision Date 05/20/1997
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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