CRC 15ULTRA

System, Applicator, Radionuclide, Remote-controlled

CAPINTEC, INC.

The following data is part of a premarket notification filed by Capintec, Inc. with the FDA for Crc 15ultra.

Pre-market Notification Details

Device IDK052595
510k NumberK052595
Device Name:CRC 15ULTRA
ClassificationSystem, Applicator, Radionuclide, Remote-controlled
Applicant CAPINTEC, INC. 540 ALPHA DR. Pittsburgh,  PA  15238
ContactMary Anne Dell
CorrespondentMary Anne Dell
CAPINTEC, INC. 540 ALPHA DR. Pittsburgh,  PA  15238
Product CodeJAQ  
CFR Regulation Number892.5700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-09-21
Decision Date2005-11-08
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.