FDA 510(k) Application Details - K223074

Device Classification Name

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510(K) Number K223074
Device Name CorNeat EverPatch
Applicant CorNeat Vision Ltd.
4 Hasheyzaf St.
Raanana 4366411 IL
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Contact Gerry Tal
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Regulation Number

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Classification Product Code QWU
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Date Received 09/30/2022
Decision Date 06/02/2023
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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