FDA 510(k) Application Details - K171077

Device Classification Name Lens, Contact (Other Material) - Daily

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510(K) Number K171077
Device Name Lens, Contact (Other Material) - Daily
Applicant CONTAMAC Ltd.
Carlton House Shire Hill
Saffron Walden CB11 3AU GB
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Contact Rob McGregor
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Regulation Number 886.5916

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Classification Product Code HQD
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Date Received 04/11/2017
Decision Date 08/01/2017
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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