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FDA 510(k) Applications Submitted by Randall Covill
FDA 510(k) Number
Submission Date
Device Name
Applicant
K170469
02/16/2017
NxStage System One Plus
NxStage Medical, Inc
K100943
04/06/2010
INVADER FACTOR II
HOLOGIC, INC.
K100987
04/09/2010
INVADER MTHFR 677
HOLOGIC, INC.
K100496
02/22/2010
INVADER MTHFR 1298
HOLOGIC, INC.
K100980
04/08/2010
INVADER FACTOR V
HOLOGIC, INC.
K081179
04/25/2008
MAMMOSITE CAVITY EVALUATION DEVICE
HOLOGIC, INC.
K143313
11/19/2014
NxStage Therapeutic Plasma Exchange (TPE) Cartridge
NxStage Medical, Inc.
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