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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 K120431
Device Name HALO90 ULTRA ABLATION CATHETER
Original Applicant
BARRX MEDICAL, INC.
540 oakmead parkway
sunnyvale,  CA  94085
Original Contact dawn chang
Regulation Number878.4400
Classification Product Code
GEI  
Subsequent Product Code
KNS  
Date Received02/13/2012
Decision Date 05/03/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Gastroenterology/Urology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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