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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lens, Spectacle (Prescription), For Reading Discomfort
510(k) Number K853758
Device Name PY-RITE
Applicant
Golden Dental Products, Inc.
16000 W. 76th. Ave.
Golden,  CO  80403
Applicant Contact DON WHITE
Correspondent
Golden Dental Products, Inc.
16000 W. 76th. Ave.
Golden,  CO  80403
Correspondent Contact DON WHITE
Regulation Number886.5844
Classification Product Code
NJH  
Date Received09/09/1985
Decision Date 12/03/1985
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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