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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 K042098
Device Name SENORX INTRODUCER
Applicant
Senorx, Inc.
11 Columbia, Suite A
Aliso Viejo,  CA  92656
Applicant Contact AMY BOUCLY
Correspondent
Senorx, Inc.
11 Columbia, Suite A
Aliso Viejo,  CA  92656
Correspondent Contact AMY BOUCLY
Regulation Number878.4400
Classification Product Code
GEI  
Date Received08/04/2004
Decision Date 08/19/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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