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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 K040919
Device Name NUCLEOTOME PROBE SET, MODEL 21200
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 Received04/08/2004
Decision Date 06/01/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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