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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 K960735
Device Name EVERGLORY SUNGLASSES
Applicant
Everglory Creations, Inc.
11 Floor , 36,
Nanking E. Rd.. Sec 2
Tapel,  TW R.O.C.
Applicant Contact BOB TSAI
Correspondent
Everglory Creations, Inc.
11 Floor , 36,
Nanking E. Rd.. Sec 2
Tapel,  TW R.O.C.
Correspondent Contact BOB TSAI
Regulation Number886.5850
Classification Product Code
HQY  
Date Received02/22/1996
Decision Date 05/13/1996
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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