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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laser, Ophthalmic
510(k) Number K100253
Device Name VISUMAX LASER KERATOME
Applicant
Carl Zeiss Meditec, AG
5160 Hacienda Dr.
Dublin,  CA  94568
Applicant Contact JUDITH A BRIMACOMBE
Correspondent
Underwriters Laboratories, Inc.
333 Pfingsten Rd.
Northbrook,  IL  60062
Correspondent Contact NED DEVINE
Regulation Number886.4390
Classification Product Code
HQF  
Subsequent Product Code
HNO  
Date Received01/28/2010
Decision Date 07/08/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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