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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 K030473
Device Name SENORX ES-300
Applicant
SENORX, INC.
11 COLUMBIA, SUITE A
ALISO VIEJO,  CA  92656
Applicant Contact AMY BOUCLY
Correspondent
INTERTEK TESTING SERVICES
2307 EAST AURORA ROAD
UNIT B7
TWINSBURG,  OH  44087
Correspondent Contact DONALD JAMES SHERRATT
Regulation Number878.4400
Classification Product Code
GEI  
Date Received02/12/2003
Decision Date 02/26/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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