FDA 510(k) Application Details - K160005

Device Classification Name Case, Contact Lens

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510(K) Number K160005
Device Name Case, Contact Lens
Applicant DANYANG CHANXIN GLASSES CASES FACTORY
HUADIAN CHUANGYE PARK, DANGUI ROAD, DEVELOPING ZONE
DANYANG CITY 212300 CN
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Contact LEMON CHEN
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Regulation Number 886.5928

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Classification Product Code LRX
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Date Received 01/04/2016
Decision Date 06/07/2016
Decision SESE - SUBST EQUIV
Classification Advisory Committee OP - Ophthalmic
Review Advisory Committee OP - Ophthalmic
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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