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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 K052947
Device Name SOURCE PRODUCTION & EQUIPMENT CO, INC., MODEL M-19 IR-192 BRACHYTHERAPY SOURCE
Applicant
SOURCE PRODUCTION & EQUIPMENT CO., INC.
113 TEAL STREET
ST. ROSE,  LA  70087
Applicant Contact JOHN J MUNRO
Correspondent
SOURCE PRODUCTION & EQUIPMENT CO., INC.
113 TEAL STREET
ST. ROSE,  LA  70087
Correspondent Contact JOHN J MUNRO
Regulation Number892.5700
Classification Product Code
JAQ  
Subsequent Product Code
KXK  
Date Received10/20/2005
Decision Date 04/19/2006
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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