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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 K060169
Device Name BARRX HALO COAGULATION SYSTEM, BARRX HALO COAGULATION GENERATOR, BARRX COAGULATION CATHETER, MODELS 2200-115A, 1520F
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 Received01/23/2006
Decision Date 04/21/2006
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
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