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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 K934374
Device Name SUNGLASSES (NON-PRESCRIPTION)
Applicant
Immmex Company , Ltd.
13f-07 # 206 Sung Kiang Rd.
Taipei, Taiwan,  TW
Applicant Contact JUDY KAN
Correspondent
Immmex Company , Ltd.
13f-07 # 206 Sung Kiang Rd.
Taipei, Taiwan,  TW
Correspondent Contact JUDY KAN
Regulation Number886.5850
Classification Product Code
HQY  
Date Received09/07/1993
Decision Date 12/08/1993
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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