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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 K101979
Device Name EXPLORER LIVER (PASSIVE TRACKING)
Applicant
PATHFINDER THERAPEUTICS, INC.
2969 ARMORY DR.
SUITE 100A
NASHVILLE,  TN  37204
Applicant Contact SENHU LI
Correspondent
PATHFINDER THERAPEUTICS, INC.
2969 ARMORY DR.
SUITE 100A
NASHVILLE,  TN  37204
Correspondent Contact SENHU LI
Regulation Number882.4560
Classification Product Code
OEW  
Date Received07/14/2010
Decision Date 02/09/2011
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
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