CRC-15BT

Calibrator, Dose, Radionuclide

CAPINTEC, INC.

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

Pre-market Notification Details

Device IDK020150
510k NumberK020150
Device Name:CRC-15BT
ClassificationCalibrator, Dose, Radionuclide
Applicant CAPINTEC, INC. 540 ALPHA DR. Pittsburgh,  PA  15238
ContactMary Anne Dell
CorrespondentMary Anne Dell
CAPINTEC, INC. 540 ALPHA DR. Pittsburgh,  PA  15238
Product CodeKPT  
CFR Regulation Number892.1360 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-01-16
Decision Date2002-08-02
Summary:summary

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