FDA 510(k) Application Details - K142275

Device Classification Name Lenses, Soft Contact, Daily Wear

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510(K) Number K142275
Device Name Lenses, Soft Contact, Daily Wear
Applicant NEO VISION CO., LTD.
1029 YEONGDOEK-DONG, GIHENUNG-GU
YONGIN-SI, 17th Floor, 4-Tower
GYEONGGI-DO KR
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Contact Kyung Hwa Kim
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Regulation Number 886.5925

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Classification Product Code LPL
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Date Received 08/15/2014
Decision Date 10/07/2014
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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