FDA 510(k) Application Details - K150590

Device Classification Name Lenses, Soft Contact, Daily Wear

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510(K) Number K150590
Device Name Lenses, Soft Contact, Daily Wear
Applicant CONTAMAC LTD
BEARWALDEN BUSINESS PARK
SAFFRON WALDEN CB11 4JX GB
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Contact Rob McGregor
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Regulation Number 886.5925

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Classification Product Code LPL
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Date Received 03/09/2015
Decision Date 07/10/2015
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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