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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 K902186
Device Name SUNGLASSES
Applicant
Creative Paper Products, Inc.
1523 Prudential Dr.
Dallas,  TX  75235
Applicant Contact DAVID HARDENBERGH
Correspondent
Creative Paper Products, Inc.
1523 Prudential Dr.
Dallas,  TX  75235
Correspondent Contact DAVID HARDENBERGH
Regulation Number886.5850
Classification Product Code
HQY  
Date Received05/14/1990
Decision Date 07/24/1990
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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