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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 K071063
Device Name LINASYS
Applicant
Pathfinder Therapeutics, Inc.
2969 Armory Dr.
Suite 100a
Nashville,  TN  37204
Applicant Contact JAMES D STEFANSIC
Correspondent
Pathfinder Therapeutics, Inc.
2969 Armory Dr.
Suite 100a
Nashville,  TN  37204
Correspondent Contact JAMES D STEFANSIC
Regulation Number882.4560
Classification Product Code
OEW  
Date Received04/16/2007
Decision Date 12/20/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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