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FDA 510(k) Applications Submitted by Jen Gregory
FDA 510(k) Number
Submission Date
Device Name
Applicant
K190321
02/13/2019
Pediatric Nailing PlatformFemur
OrthoPediatrics, Corp.
K190324
02/13/2019
OrthoPediatrics Cannulated Screw System
Orthopediatrics, Corp
K190992
04/15/2019
OrthoPediatrics PediFoot Deformity Corrections System
OrthoPediatrics, Corp
K130265
02/04/2013
CONTOUR NEXT EZ BLOOD GLUCOSE METER
BAYER HEALTHCARE LLC
K222105
07/18/2022
RESPONSE 5.5/6.0 Cannulated Screw System
OrthoPediatrics Corp.
K160430
02/16/2016
Contour Next Link Wireless Blood Glucose Monitoring System, Contour Next Blood Glucose Monitoring System
Ascensia Diabetes Care US Inc.
K150942
04/08/2015
Contour Next USB Blood Glucose Monitoring System
BAYER HEALTHCARE
K151742
06/29/2015
Contour Next Control Solution
BAYER HEALTHCARE
K162336
08/22/2016
Contour Next EZ Blood Glucose Monitoring System
Ascensia Diabetes Care US Inc.
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