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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tomography, Optical Coherence
510(k) Number K083291
Device Name CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER AND MACULAR NORMATIVE DATABASES, MODEL 4000
Applicant
CARL ZEISS MEDITEC INC
5160 HACIENDA DR.
DUBLIN,  CA  94568
Applicant Contact JUDITH A BRIMACOMBE
Correspondent
CARL ZEISS MEDITEC INC
5160 HACIENDA DR.
DUBLIN,  CA  94568
Correspondent Contact JUDITH A BRIMACOMBE
Regulation Number886.1570
Classification Product Code
OBO  
Date Received11/07/2008
Decision Date 05/05/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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