FDA 510(k) Application Details - K173958

Device Classification Name Lenses, Soft Contact, Daily Wear

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510(K) Number K173958
Device Name Lenses, Soft Contact, Daily Wear
Applicant Visco Vision Inc
No. 1, Xingye St., Guishan Dist.,
Taoyuan 33341 TW
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Contact Evan Huang
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Regulation Number 886.5925

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Classification Product Code LPL
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Date Received 12/28/2017
Decision Date 04/03/2018
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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