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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Retractor
510(k) Number K980588
Device Name CLARUS ENDOSCOPIC DISCECTOMY SYSTEM SITETRAC MODEL 6000
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 Number878.4800
Classification Product Code
GAD  
Date Received02/17/1998
Decision Date 08/18/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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