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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscope Holder
510(k) Number K971584
Device Name CLARUS MODEL 2127-900 SERIES ENDOSCOPE ADATER (2127-900 SERIES)
Applicant
Clarus Medical Systems, Inc.
1000 Boone Ave. N.
#100
Minneapolis,  MN  55427
Applicant Contact DALE SAPPENFIELD
Correspondent
Clarus Medical Systems, Inc.
1000 Boone Ave. N.
#100
Minneapolis,  MN  55427
Correspondent Contact DALE SAPPENFIELD
Regulation Number876.1500
Classification Product Code
OCV  
Date Received04/30/1997
Decision Date 05/23/1997
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
Predetermined Change
Control Plan Authorized		 No
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