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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 K013940
Device Name LASER SYSTEM YELLOWSTAR
Applicant
Asclepion-Meditec AG
2961 W. Mac Arthur Blvd. #133
Santa Ana,  CA  92704
Applicant Contact WILLIAM KELLEY
Correspondent
Asclepion-Meditec AG
2961 W. Mac Arthur Blvd. #133
Santa Ana,  CA  92704
Correspondent Contact WILLIAM KELLEY
Regulation Number878.4810
Classification Product Code
GEX  
Date Received11/29/2001
Decision Date 02/26/2002
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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