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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Camera, Ophthalmic, Ac-Powered
510(k) Number K053044
Device Name OPTO GLOBAL DIGITAL FUNDUS CAMERA SYSTEM MODEL ADS 1.5
Applicant
Opto Global, Inc.
4021 Daggett Dr.
Granite Bay,  CA  95746
Applicant Contact MARK T FUKUHARA
Correspondent
Underwriters Laboratories, Inc.
1655 Scott Blvd.
Santa Clara,  CA  95050
Correspondent Contact LORINDA BADALIAN
Regulation Number886.1120
Classification Product Code
HKI  
Subsequent Product Codes
NFF   NFG  
Date Received10/28/2005
Decision Date 01/24/2006
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
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