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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Laser Surgical Instrument
510(k) Number K021848
Device Name CLARUS STRAIGHT FIRING LASER FIBER; CLARUS SIDE FIRING LASER FIBER; MODELS 1150, 1160
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 Number878.4810
Classification Product Code
GEX  
Date Received06/05/2002
Decision Date 09/03/2002
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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