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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 K922881
Device Name CLARUS MODELS 1100, 1101, 1102, 1103 LASER DISC
Applicant
Clarus Medical Systems, Inc.
2605 Fernbrook La
Minneapolis,  MN  55447
Applicant Contact GREGORY J MATHISON
Correspondent
Clarus Medical Systems, Inc.
2605 Fernbrook La
Minneapolis,  MN  55447
Correspondent Contact GREGORY J MATHISON
Regulation Number878.4810
Classification Product Code
GEX  
Date Received06/16/1992
Decision Date 11/16/1992
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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