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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 K101111
Device Name HALO ABLATION CATHETER MODEL 90-9100, HALO90 ULTRA ABLATION CATHETER MODEL 90-9200
Applicant
BARRX MEDICAL INC
540 OAKMEAD PARKWAY
SUNNYVALE,  CA  94085
Applicant Contact VIORICA FILIMON
Correspondent
BARRX MEDICAL INC
540 OAKMEAD PARKWAY
SUNNYVALE,  CA  94085
Correspondent Contact VIORICA FILIMON
Regulation Number878.4400
Classification Product Code
GEI  
Date Received04/21/2010
Decision Date 06/18/2010
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
Recalls CDRH Recalls
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