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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 K951168
Device Name CRYSTAL
Applicant
Crystal Optical Co., Ltd.
10 Floor , No 56, Ln. 452
Da-Ye Rd.
Taipei,  TW
Applicant Contact YUNG-CHI HSU
Correspondent
Crystal Optical Co., Ltd.
10 Floor , No 56, Ln. 452
Da-Ye Rd.
Taipei,  TW
Correspondent Contact YUNG-CHI HSU
Regulation Number886.5850
Classification Product Code
HQY  
Date Received03/15/1995
Decision Date 05/12/1995
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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