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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Anomaloscope
510(k) Number K860174
Device Name GUNKEL CHROMAGRAPH COLOR VISION TESTER
Applicant
Chromagraphics, Inc.
120 Center Dr.
Apt. 709
Bethesda,  MD  20814
Applicant Contact RALPH D GUNKEL,O.D.
Correspondent
Chromagraphics, Inc.
120 Center Dr.
Apt. 709
Bethesda,  MD  20814
Correspondent Contact RALPH D GUNKEL,O.D.
Regulation Number886.1070
Classification Product Code
HIW  
Date Received01/17/1986
Decision Date 04/04/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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