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FDA 510(k) Applications Submitted by Shelly Harris
FDA 510(k) Number
Submission Date
Device Name
Applicant
K110028
01/05/2011
MASIMO RADICAL Y PULSE CO-OXIMETER
MASIMO CORPORATION
K110723
03/16/2011
M-LNCS OXIMETRY SENSORS, REPROCESSED M-LNCS OXIMETRY SENSORS
MASIMO CORPORATION
K160979
04/07/2016
Inclusive Abutments
PRISMATIK DENTALCRAFT, INC.
K131249
05/01/2013
ON-Q PAINBUSTER, ON-Q C-BLOC, HOMEPUMP ECLIPSE, HOMEPUMP C-SERIES
I-FLOW LLC
K181436
06/01/2018
OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health Mono II Rapid Test
Sekisui Diagnostics, LLC
K182001
07/26/2018
Acucy Influenza A&B Test with the Acucy System
Sekisui Diagnostics, LLC
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