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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 K080565
Device Name MODIFICATION TO: SAVI APPLICATOR KIT
Applicant
Cianna Medical, Inc.
6 Journey, Suite 125
Aliso Viejo,  CA  92656
Applicant Contact GARY MOCNIK
Correspondent
Cianna Medical, Inc.
6 Journey, Suite 125
Aliso Viejo,  CA  92656
Correspondent Contact GARY MOCNIK
Regulation Number892.5700
Classification Product Code
JAQ  
Date Received02/29/2008
Decision Date 04/04/2008
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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