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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 DRIVE
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
Recalls CDRH Recalls
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