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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 K003236
Device Name RETINADX
Applicant
REGULATORY ASSOCIATES, INC.
777 SOUTH WADESWORTH BLVD.,
BLDG. 2, SUITE 102
LAKEWOOD,  CO  80226
Applicant Contact Kevin Walls
Correspondent
REGULATORY ASSOCIATES, INC.
777 SOUTH WADESWORTH BLVD.,
BLDG. 2, SUITE 102
LAKEWOOD,  CO  80226
Correspondent Contact Kevin Walls
Regulation Number886.1120
Classification Product Code
HKI  
Date Received10/17/2000
Decision Date 11/02/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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