The following data is part of a premarket notification filed by Capintec, Inc. with the FDA for Crc-15bt.
Device ID | K020150 |
510k Number | K020150 |
Device Name: | CRC-15BT |
Classification | Calibrator, Dose, Radionuclide |
Applicant | CAPINTEC, INC. 540 ALPHA DR. Pittsburgh, PA 15238 |
Contact | Mary Anne Dell |
Correspondent | Mary Anne Dell CAPINTEC, INC. 540 ALPHA DR. Pittsburgh, PA 15238 |
Product Code | KPT |
CFR Regulation Number | 892.1360 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-01-16 |
Decision Date | 2002-08-02 |
Summary: | summary |