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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Arthroscope
510(k) Number K011454
Device Name SPINE SCOPE, MODEL 2180
Applicant
Clarus Medical, LLC
1000 Boone Ave. N.
Minneapolis,  MN  55427
Applicant Contact TOM BARTHEL
Correspondent
Clarus Medical, LLC
1000 Boone Ave. N.
Minneapolis,  MN  55427
Correspondent Contact TOM BARTHEL
Regulation Number888.1100
Classification Product Code
HRX  
Date Received05/11/2001
Decision Date 12/13/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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