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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 K973407
Device Name SUNGLASSES (NON-PRESCRIPTION)
Applicant
Pacific Optical Co. , Ltd.
#90, Hong Dian Rd., S.
Wenzhou, Zhejiang,  CN 325003
Applicant Contact EDWARD WANG
Correspondent
Pacific Optical Co. , Ltd.
#90, Hong Dian Rd., S.
Wenzhou, Zhejiang,  CN 325003
Correspondent Contact EDWARD WANG
Regulation Number886.5850
Classification Product Code
HQY  
Date Received09/09/1997
Decision Date 09/30/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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