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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 K061241
Device Name BIOLUCENT APPLICATOR, MODEL RTA-XX
Applicant
BIOLUCENT, INC.
6 JOURNEY, SUITE 325
ALISO VIEJO,  CA  92656
Applicant Contact J. DAVID CAMPBELL
Correspondent
BIOLUCENT, INC.
6 JOURNEY, SUITE 325
ALISO VIEJO,  CA  92656
Correspondent Contact J. DAVID CAMPBELL
Regulation Number892.5700
Classification Product Code
JAQ  
Date Received05/03/2006
Decision Date 07/28/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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