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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sunglasses (Non-Prescription Including Photosensitive)
510(k) Number K953245
Device Name NYX GOLF VISION SYSTEM
Applicant
Nyx Golf, Inc.
5010 Purdue
Dallas,  TX  75209
Applicant Contact CLIFTON BEANE
Correspondent
Nyx Golf, Inc.
5010 Purdue
Dallas,  TX  75209
Correspondent Contact CLIFTON BEANE
Regulation Number886.5850
Classification Product Code
HQY  
Date Received07/07/1995
Decision Date 07/19/1995
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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