FDA 510(k) Application Details - K040913

Device Classification Name Device,Analysis,Anterior Segment

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510(K) Number K040913
Device Name Device,Analysis,Anterior Segment
Applicant BAUSCH & LOMB
180 VIA VERDE DRIVE
SAN DIMAS, CA 91773 US
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Contact DAVID THOMAS
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Regulation Number 886.1850

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Classification Product Code MXK
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Date Received 04/08/2004
Decision Date 07/23/2004
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 Y
Expedited Review



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