FDA 510(k) Application Details - K140409

Device Classification Name Cup, Eye

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510(K) Number K140409
Device Name Cup, Eye
Applicant APOTHECARY PRODUCTS, INC.
11750 12TH AVE. SOUTH
BURNSVILLE, MN 55337 US
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Contact JAMES JENKINS
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Regulation Number 000.0000

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Classification Product Code LXQ
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Date Received 02/18/2014
Decision Date 07/09/2014
Decision SESE - SUBST EQUIV
Classification Advisory Committee -
Review Advisory Committee OP - Ophthalmic
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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