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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 K092822
Device Name CAPRI APPLICATOR
Applicant
Vivaray, Inc.
3264 Alpine Rd.
Portola Valley,  CA  94028
Applicant Contact GEORGE HERMANN
Correspondent
Vivaray, Inc.
3264 Alpine Rd.
Portola Valley,  CA  94028
Correspondent Contact GEORGE HERMANN
Regulation Number892.5700
Classification Product Code
JAQ  
Date Received09/14/2009
Decision Date 11/03/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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