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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name lacrimal stents and intubation sets
510(k) Number K113867
Models LDC213T, LDC315T, LDC508T
Device Name LACRICATH LACRIMAL DUCT CATHETER
Original Applicant
QUEST MEDICAL, INC.
one allentown pkwy.
allen,  TX  75002
Original Contact amy clendening-wheeler
Classification Product Code
OKS  
Date Received12/30/2011
Decision Date 10/19/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Ophthalmic
Review Advisory Committee Neurology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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