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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 K932999
Device Name NEW STAR, TAE HAN OPTICAL
Applicant
J.B. Eyewear, Inc.
8000 NW 31st., Suite 19
Miami,  FL  33122
Applicant Contact BONG KIM
Correspondent
J.B. Eyewear, Inc.
8000 NW 31st., Suite 19
Miami,  FL  33122
Correspondent Contact BONG KIM
Regulation Number886.5842
Classification Product Code
HQZ  
Date Received06/18/1993
Decision Date 09/09/1993
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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