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FDA 510(k) Applications Submitted by James J Gibson Jr.
FDA 510(k) Number
Submission Date
Device Name
Applicant
K170001
01/03/2017
Acuity 85 (Oprifocon A) Rigid Gas Permeable Contact Lens
Acuity Polymers, Inc.
K041442
06/01/2004
EP-4 CLINICAL STIMUTATOR
EP MEDSYSTEMS
K143196
11/06/2014
syngo.CT Lung CAD
SIEMENS AG MEDICAL SOLUTIONS
K033963
12/22/2003
EP DEFLECTABLE CATHETERS
EP MEDSYSTEMS, INC.
K180220
01/25/2018
SAGICO OSI Spinal System by Osimplant
Spinal Analytics & Geometrical Implant Co, LLC
K974088
10/30/1997
CODMAN INTRACRANIAL BOLT
JOHNSON & JOHNSON PROFESSIONALS, INC.
K050702
03/18/2005
NEUROSYSTEMS 1TM MONITOR
NEUROSYSTEMS LLC
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