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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 K041929
Device Name MAMMOSITE II RADIATION THERAPY SYSTEM (RTS) TRAY, MAMMOSITE HDR AFTERLOADER ACCESSORIES TRAY
Applicant
Proxima Therapeutics, Inc.
2555 Marconi Dr., Suite 220
Alpharetta,  GA  30005
Applicant Contact MARTINE D SCHNEIDER
Correspondent
Proxima Therapeutics, Inc.
2555 Marconi Dr., Suite 220
Alpharetta,  GA  30005
Correspondent Contact MARTINE D SCHNEIDER
Regulation Number892.5700
Classification Product Code
JAQ  
Date Received07/19/2004
Decision Date 08/26/2004
Decision Substantially Equivalent (SESE)
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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