FDA 510(k) Application Details - K140290

Device Classification Name Lacrimal Stents And Intubation Sets

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510(K) Number K140290
Device Name Lacrimal Stents And Intubation Sets
Applicant LJT SURGICAL LTD
5600 WISCONSIN AVE. #509
CHEVY CHASE, MD 20815 US
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Contact PATSY J TRISLER, JD, RAC
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Regulation Number 000.0000

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Classification Product Code OKS
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Date Received 02/05/2014
Decision Date 12/02/2014
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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