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FDA 510(k) Applications Submitted by KIMBERLY MCCOY
FDA 510(k) Number
Submission Date
Device Name
Applicant
DEN180013
03/15/2018
PREVENA 125 and PREVENA PLUS 125 Therapy Units
KCI USA, Inc.
K180855
04/02/2018
Prevena Plus Incision Management System, Prevena Plus Duo Incision Management System
KCI USA, Inc.
K051301
05/19/2005
PROXIMATE PPH HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES
ETHICON ENDO-SURGERY, INC.
K181507
06/07/2018
PREVENA RESTOR(TM) Incision Management System
KCI USA, Inc.
K141804
07/03/2014
POLARIS SPINAL SYSTEM - HA COATED
BIOMET SPINE LLC,
K122417
08/08/2012
SCOPEVALET DISPOSABLE BIOPSY VALVE
THE RUHOF CORP.
K133518
11/15/2013
MAXAN ANTERIOR CERVICAL PLATE SYSTEM
BIOMET SPINE (AKA EBI, LLC)
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