FDA 510(k) Application Details - K222954

Device Classification Name Lenses, Soft Contact, Daily Wear

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510(K) Number K222954
Device Name Lenses, Soft Contact, Daily Wear
Applicant Innova Vision Inc.
2F., No. 20, Prosperity Rd. 1, Hsinchu Science Park
Hsinchu 300091 TW
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Contact Kari Huang
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Regulation Number 886.5925

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Classification Product Code LPL
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Date Received 09/27/2022
Decision Date 03/13/2023
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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