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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 K942783
Device Name NON-PRESCRIPTION SUNGLASSES
Applicant
Sunpoint Import Co., Inc.
14145 Proctor Ave.
Suite 5
City Of Industry,  CA  91746
Applicant Contact CHEN M LU
Correspondent
Sunpoint Import Co., Inc.
14145 Proctor Ave.
Suite 5
City Of Industry,  CA  91746
Correspondent Contact CHEN M LU
Regulation Number886.5850
Classification Product Code
HQY  
Date Received06/14/1994
Decision Date 07/15/1994
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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