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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 K941695
Device Name SUNGLASSES
Applicant
Sun Creations, Inc.
3308 Industry Dr.
Signal Hill,  CA  90806
Applicant Contact JAMES K DILLON
Correspondent
Sun Creations, Inc.
3308 Industry Dr.
Signal Hill,  CA  90806
Correspondent Contact JAMES K DILLON
Regulation Number886.5850
Classification Product Code
HQY  
Date Received04/06/1994
Decision Date 04/29/1994
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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