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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 K952939
Device Name ROYAL FLASH
Applicant
Royal Flash Enterprise Co. , Ltd.
# 192, Section 2
Shu-Lin St.
Tainan City,  TW
Applicant Contact PETER CHIU
Correspondent
Royal Flash Enterprise Co. , Ltd.
# 192, Section 2
Shu-Lin St.
Tainan City,  TW
Correspondent Contact PETER CHIU
Regulation Number886.5850
Classification Product Code
HQY  
Date Received06/26/1995
Decision Date 08/07/1995
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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