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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 K854879
Device Name SUNGLASSES
Applicant
Jarnger Trading Co., Ltd.
# 858 Ting Chou Rd.
Taipei
Taiwan R.O.C.,  TW
Applicant Contact LIISHYUE LIN
Correspondent
Jarnger Trading Co., Ltd.
# 858 Ting Chou Rd.
Taipei
Taiwan R.O.C.,  TW
Correspondent Contact LIISHYUE LIN
Regulation Number886.5850
Classification Product Code
HQY  
Date Received12/06/1985
Decision Date 02/04/1986
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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