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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K083737
Device Name HALO ABLATION CATHETER
Applicant
Barrx Medical, Incorporated
540 Oakmead Pkwy.
Sunnyvale,  CA  94085
Applicant Contact VIORICA FILIMON
Correspondent
Barrx Medical, Incorporated
540 Oakmead Pkwy.
Sunnyvale,  CA  94085
Correspondent Contact VIORICA FILIMON
Regulation Number878.4400
Classification Product Code
GEI  
Date Received12/16/2008
Decision Date 02/10/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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