FDA 510(k) Application Details - K142914

Device Classification Name Lacrimal Stents And Intubation Sets

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510(K) Number K142914
Device Name Lacrimal Stents And Intubation Sets
Applicant ARMADILLO BIOMEDICAL, LLC
5363 Balbao Blvd., Suite 246
Encino, CA 91316 US
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Contact Bruce Becker, M.D.
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Regulation Number 000.0000

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Classification Product Code OKS
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Date Received 10/07/2014
Decision Date 01/12/2015
Decision SESE - SUBST EQUIV
Classification Advisory Committee -
Review Advisory Committee OP - Ophthalmic
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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