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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 K902385
Device Name SUNSHADES, ACRYLIC LENSES, ORDER #SG-01
Applicant
Tel-Time Products
230 W. Hwy.67
P.O. Box 512
Keene,  TX  76059
Applicant Contact TOM J KIMBROW
Correspondent
Tel-Time Products
230 W. Hwy.67
P.O. Box 512
Keene,  TX  76059
Correspondent Contact TOM J KIMBROW
Regulation Number886.5850
Classification Product Code
HQY  
Date Received05/30/1990
Decision Date 07/05/1990
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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