FDA 510(k) Application Details - K121324

Device Classification Name Lenses, Soft Contact, Daily Wear

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510(K) Number K121324
Device Name Lenses, Soft Contact, Daily Wear
Applicant ADVANCED VISION TECHNOLOGIES
806 KIMBALL AVE
GRAND JUNCTION, CO 81501 US
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Contact MARTIN DALSING
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Regulation Number 886.5925

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Classification Product Code LPL
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Date Received 05/02/2012
Decision Date 08/23/2012
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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