MAMMOSITE RADIATION THERAPY SYSTEM (RTS) TRAY, MAMMOSITE HDR AFTERLOADER ACCESSORIES TRAY

System, Applicator, Radionuclide, Remote-controlled

PROXIMA THERAPEUTICS, INC.

The following data is part of a premarket notification filed by Proxima Therapeutics, Inc. with the FDA for Mammosite Radiation Therapy System (rts) Tray, Mammosite Hdr Afterloader Accessories Tray.

Pre-market Notification Details

Device IDK030558
510k NumberK030558
Device Name:MAMMOSITE RADIATION THERAPY SYSTEM (RTS) TRAY, MAMMOSITE HDR AFTERLOADER ACCESSORIES TRAY
ClassificationSystem, Applicator, Radionuclide, Remote-controlled
Applicant PROXIMA THERAPEUTICS, INC. 2555 MARCONI DRIVE, SUITE 220 Alpharetta,  GA  30005 -2066
ContactMartine D Schneider
CorrespondentMartine D Schneider
PROXIMA THERAPEUTICS, INC. 2555 MARCONI DRIVE, SUITE 220 Alpharetta,  GA  30005 -2066
Product CodeJAQ  
CFR Regulation Number892.5700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-02-21
Decision Date2003-05-21
Summary:summary

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