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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 K936027
Device Name SPORTS RADIO SUNGLASSES
Applicant
Vast Lea Enterprise Co. , Ltd.
11f-2, # 109, Sec. 3
Ho Ping E. Rd.
Taipei,  TW
Applicant Contact VINCENT WU-VAST LEA
Correspondent
Vast Lea Enterprise Co. , Ltd.
11f-2, # 109, Sec. 3
Ho Ping E. Rd.
Taipei,  TW
Correspondent Contact VINCENT WU-VAST LEA
Regulation Number886.5850
Classification Product Code
HQY  
Date Received12/17/1993
Decision Date 03/14/1994
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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