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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 K092487
Device Name HALOFLEX ENERGY GENERATOR, MODELS 1190A-115A AND 1190A-230A
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 Received08/13/2009
Decision Date 11/10/2009
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
Recalls CDRH Recalls
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