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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name source, brachytherapy, radionuclide
510(k) Number K030534
Device Name VARISEED 7.1
Applicant
VARIAN MEDICAL SYSTEMS
700 HARRIS STREET
SUITE 109
CHARLOTTESVILLE,  VA  22903 -1038
Applicant Contact LINDA S NASH
Correspondent
VARIAN MEDICAL SYSTEMS
700 HARRIS STREET
SUITE 109
CHARLOTTESVILLE,  VA  22903 -1038
Correspondent Contact LINDA S NASH
Regulation Number892.5730
Classification Product Code
KXK  
Date Received02/20/2003
Decision Date 05/21/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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