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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Tester, Color Vision
510(k) Number K873908
Device Name H.R.R. PSEUDOISOCHROMATIC COLOR BLINDNESS TEST BK.
Applicant
Richmond Products, Inc.
1021 So Rogers Cir.
Boca Raton,  FL  33487
Applicant Contact LLOYD POWELL
Correspondent
Richmond Products, Inc.
1021 So Rogers Cir.
Boca Raton,  FL  33487
Correspondent Contact LLOYD POWELL
Regulation Number886.1170
Classification Product Code
HIT  
Date Received09/25/1987
Decision Date 12/23/1987
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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