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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 K062830
Device Name BIOLUCENT APPLICATOR KIT
Applicant
Biolucent, Inc.
6 Journey, Suite 325
Aliso Viejo,  CA  92656
Applicant Contact DAVE CAMPBELL
Correspondent
Biolucent, Inc.
6 Journey, Suite 325
Aliso Viejo,  CA  92656
Correspondent Contact DAVE CAMPBELL
Regulation Number892.5700
Classification Product Code
JAQ  
Date Received09/20/2006
Decision Date 10/20/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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