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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 K080557
Device Name BARRX MODELS HALO360 AND HALO360+ COAGULATION CATHETERS
Applicant
BARRX MEDICAL, INCORPORATED
540 OAKMEAD PARKWAY
SUNNYVALE,  CA  94085
Applicant Contact VIORICA FILIMON
Correspondent
BARRX MEDICAL, INCORPORATED
540 OAKMEAD PARKWAY
SUNNYVALE,  CA  94085
Correspondent Contact VIORICA FILIMON
Regulation Number878.4400
Classification Product Code
GEI  
Date Received02/28/2008
Decision Date 04/02/2008
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
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