FDA 510(k) Application Details - K140026

Device Classification Name Plug, Punctum

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510(K) Number K140026
Device Name Plug, Punctum
Applicant LACRIMEDICS, INC.
2620 Williamson Pl NW Ste 113
Du Pont, WA 98327 US
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Contact REBECCA DUTTON
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Regulation Number 000.0000

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Classification Product Code LZU
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Date Received 01/06/2014
Decision Date 06/03/2014
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

FDA Source Information for K140026


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