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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Frame, Spectacle
510(k) Number K945350
Device Name FRAME, SPECTACLES
Applicant
Taiwan Eva Industrial Co., Inc.
P.O. Box 1445
Kaohsiung,  TW
Applicant Contact HOLLY LIN
Correspondent
Taiwan Eva Industrial Co., Inc.
P.O. Box 1445
Kaohsiung,  TW
Correspondent Contact HOLLY LIN
Regulation Number886.5842
Classification Product Code
HQZ  
Date Received09/14/1994
Decision Date 12/13/1994
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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