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510(k) K093494

Device
LINASYS IMAGE-GUIDED LIVER SURGERY SYSTEM
Applicant
PATHFINDER THERAPEUTICS, INC.
510(k) number
K093494
Product code
OEW  
Decision
Substantially Equivalent (SESE)
Decision date
2010-03-30
Date received
2009-11-10
Regulation
882.4560
Classification name
Tracking, Soft Tissue, Intraoperative
Medical specialty
Neurology
Review panel
General & Plastic Surgery
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
CRAIG HENDERSON
Address
2969 Armory Dr. Suite 100a Nashville TN US 37204 37204

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code OEW  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K143024CAS-One LiverCascination AG2015-04-28
K101979EXPLORER LIVER (PASSIVE TRACKING)Pathfinder Therapeutics, Inc.2011-02-09
K071063LINASYSPathfinder Therapeutics, Inc.2007-12-20

Legacy Summary#

summary

FDA Review#

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