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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tracking, Soft Tissue, Intraoperative
510(k) Number K093494
Device Name LINASYS IMAGE-GUIDED LIVER SURGERY SYSTEM
Applicant
Pathfinder Therapeutics, Inc.
2969 Armory Dr.
Suite 100a
Nashville,  TN  37204
Applicant Contact CRAIG HENDERSON
Correspondent
Pathfinder Therapeutics, Inc.
2969 Armory Dr.
Suite 100a
Nashville,  TN  37204
Correspondent Contact CRAIG HENDERSON
Regulation Number882.4560
Classification Product Code
OEW  
Date Received11/10/2009
Decision Date 03/30/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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