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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 K062314
Device Name HORUS LASER KERATOME
Applicant
Carl Zeiss Meditec, AG
5160 Hacienda Dr.
Dublin,  CA  94568
Applicant Contact KENT W JONES
Correspondent
Carl Zeiss Meditec, AG
5160 Hacienda Dr.
Dublin,  CA  94568
Correspondent Contact KENT W JONES
Regulation Number878.4810
Classification Product Code
GEX  
Subsequent Product Code
HNO  
Date Received08/08/2006
Decision Date 12/22/2006
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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