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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 K935114
Device Name SUNGLASSES (NON-PRESCRIPTION)
Applicant
Promising Enterprise CO , Ltd.
62, Aly. 84, Section 5
An-Ho Rd.
Tainan,  TW
Applicant Contact CHENG H CHEN
Correspondent
Promising Enterprise CO , Ltd.
62, Aly. 84, Section 5
An-Ho Rd.
Tainan,  TW
Correspondent Contact CHENG H CHEN
Regulation Number886.5850
Classification Product Code
HQY  
Date Received10/25/1993
Decision Date 02/22/1994
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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