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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 K043246
Device Name BRACHYSOURCE BRACHYTHERAPY SEED IMPLANTS
Applicant
C.R. BARD, INC.
8195 INDUSTRIAL BLVD
COVINGTON,  GA  30014
Applicant Contact JOHN C KNORPP
Correspondent
C.R. BARD, INC.
8195 INDUSTRIAL BLVD
COVINGTON,  GA  30014
Correspondent Contact JOHN C KNORPP
Regulation Number892.5730
Classification Product Code
KXK  
Date Received11/23/2004
Decision Date 02/02/2005
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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