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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 K060680
Device Name ATRILAZE SURGICAL ABLATION SYSTEM
Applicant
Medical Cv, Inc.
9725 S. Robert Trl.
Inver Grove Heights,  MN  55077
Applicant Contact DENNY STEGER
Correspondent
Medical Cv, Inc.
9725 S. Robert Trl.
Inver Grove Heights,  MN  55077
Correspondent Contact DENNY STEGER
Regulation Number878.4810
Classification Product Code
GEX  
Subsequent Product Code
OCL  
Date Received03/15/2006
Decision Date 04/11/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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