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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 K033354
Device Name FEMTEC LASER MICROKERATOME
Applicant
20/10 Perfect Vision Optische Gerate GmbH
21911 Erie Lane
Lake Forest,  CA  92630
Applicant Contact CAROL PATTERSON
Correspondent
20/10 Perfect Vision Optische Gerate GmbH
21911 Erie Lane
Lake Forest,  CA  92630
Correspondent Contact CAROL PATTERSON
Regulation Number878.4810
Classification Product Code
GEX  
Subsequent Product Code
HNO  
Date Received10/20/2003
Decision Date 02/18/2004
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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