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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ophthalmoscope, Ac-Powered
510(k) Number K033123
Device Name STRATUSOCT WITH RNFL & MACULA NORMATIVE DATABASE
Applicant
Carl Zeiss Meditec, Inc.
5160 Hacienda Dr.
Dublin,  CA  94568
Applicant Contact R. MICHAEL CROMPTON
Correspondent
Carl Zeiss Meditec, Inc.
5160 Hacienda Dr.
Dublin,  CA  94568
Correspondent Contact R. MICHAEL CROMPTON
Regulation Number886.1570
Classification Product Code
HLI  
Subsequent Product Code
IYO  
Date Received09/30/2003
Decision Date 04/20/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Radiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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