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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 K070659
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 Received03/09/2007
Decision Date 04/04/2007
Decision SE - With Limitations (SESU)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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