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FDA 510(k) Applications Submitted by KELSEY LEE
FDA 510(k) Number
Submission Date
Device Name
Applicant
K100146
01/19/2010
EVOLVE EPS ORTHOLOC
WRIGHT MEDICAL TECHNOLOGY, INC.
K100359
02/12/2010
DARCO HEADED CANNULATED SCREW
WRIGHT MEDICAL TECHNOLOGY, INC.
K130796
03/22/2013
VITAL SYNC INFORMATICS MANAGER & VIRTUAL PATIENT MONITORING PLATFORM
COVIDIEN
K100886
03/30/2010
INBONE II TOTAL ANKLE REPLACEMENT
WRIGHT MEDICAL TECHNOLOGY, INC.
K101165
04/26/2010
PRO-TOE VO HAMMERTOW IMPLANT SYSTEM
WRIGHT MEDICAL TECHNOLOGY, INC.
K151252
05/12/2015
Puritan Bennett 840 Series Ventilator System
Covidien LP
K142298
08/18/2014
Shiley Neonatal, Pediatric & Pediatric Long Tracheostomy Tubes with TaperGuard Cuff
Covidien
K102352
08/19/2010
EVOLVE EPS ORTHOLOC
WRIGHT MEDICAL TECHNOLOGY, INC.
K132604
08/20/2013
VITAL SYNC INFORMATICS MANAGER & VIRTUAL PATIENT MONITORING PLATFORM
COVIDIEN
K123002
09/27/2012
VITAL SYNC SYSTEM
COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT, INC.
K162738
09/30/2016
Puritan Bennett 980 Ventilator System
Covidien
K103374
11/17/2010
INBONE TOTAL ANKLE SYSTEM MODEL 200347902
WRIGHT MEDICAL TECHNOLOGY, INC.
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