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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 K934463
Device Name SPECTACLE FRAME
Applicant
Good Bond Industrial Corp.
# 17, Aly. 171, Ln. 87,
Pei Yuan St.
Tainan,  TW
Applicant Contact WANG CHING-YUN
Correspondent
Good Bond Industrial Corp.
# 17, Aly. 171, Ln. 87,
Pei Yuan St.
Tainan,  TW
Correspondent Contact WANG CHING-YUN
Regulation Number886.5842
Classification Product Code
HQZ  
Date Received09/10/1993
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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