FDA 510(k) Application Details - K142717

Device Classification Name Case, Contact Lens

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510(K) Number K142717
Device Name Case, Contact Lens
Applicant Ni Hau Industrial Co., Ltd.
No. 15, Alley 125, Lane 318, Section 2, An Ho Road
Tainan City 70967 TW
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Contact Lyn Chiu
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Regulation Number 886.5928

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Classification Product Code LRX
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Date Received 09/23/2014
Decision Date 05/07/2015
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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