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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Marker, Radiographic, Implantable
510(k) Number K080698
Device Name GEL MARK ULTRACOR BIOPSY SITE MARKER, MODEL: GMUC-17GGP
Applicant
Senorx, Inc.
11 Columbia
Aliso Viejo,  CA  92656
Applicant Contact EBEN GORDON
Correspondent
Senorx, Inc.
11 Columbia
Aliso Viejo,  CA  92656
Correspondent Contact EBEN GORDON
Regulation Number878.4300
Classification Product Code
NEU  
Date Received03/12/2008
Decision Date 03/31/2008
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
Predetermined Change
Control Plan Authorized		 No
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