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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Applicator, Radionuclide, Remote-Controlled
510(k) Number K082264
Device Name CONTURA LUMEN MARKER
Applicant
Senorx, Inc.
11 Columbia
Aliso Viejo,  CA  92656
Applicant Contact EBEN GORDON
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number892.5700
Classification Product Code
JAQ  
Date Received08/11/2008
Decision Date 09/12/2008
Decision SE - With Limitations (SESU)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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