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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 K944915
Device Name AXIOM, SUNFAST
Applicant
Axiom Ent. Co., Ltd.
218 Chung-Cheng 2nd Rd.
Kaohsiung,  TW R.O.C.
Applicant Contact WINSTON W SU
Correspondent
Axiom Ent. Co., Ltd.
218 Chung-Cheng 2nd Rd.
Kaohsiung,  TW R.O.C.
Correspondent Contact WINSTON W SU
Regulation Number886.5850
Classification Product Code
HQY  
Subsequent Product Code
HQZ  
Date Received10/06/1994
Decision Date 11/22/1994
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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