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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Ablation, Microwave And Accessories
510(k) Number K072870
FOIA Releasable 510(k) K072870
Device Name MICROWAVE TISSUE COAGULATION SYSTEM (MTCS)
Applicant
Foundry Newco X, Inc.
199 Jefferson Dr.
Menlo Park,  CA  94025
Applicant Contact GREGORY MATHISON
Correspondent
Foundry Newco X, Inc.
199 Jefferson Dr.
Menlo Park,  CA  94025
Correspondent Contact GREGORY MATHISON
Regulation Number878.4400
Classification Product Code
NEY  
Date Received10/09/2007
Decision Date 01/14/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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