The following data is part of a premarket notification filed by Capintec, Inc. with the FDA for Crc 25 Series (crc 25r, Crc 25pet, Crc 25w) Dose Calibrators.
| Device ID | K071396 |
| 510k Number | K071396 |
| Device Name: | CRC 25 SERIES (CRC 25R, CRC 25PET, CRC 25W) DOSE CALIBRATORS |
| Classification | Calibrator, Dose, Radionuclide |
| Applicant | CAPINTEC, INC. 620 ALPHA DR. Pittsburgh, PA 15241 |
| Contact | Mary Anne Dell |
| Correspondent | Mary Anne Dell CAPINTEC, INC. 620 ALPHA DR. Pittsburgh, PA 15241 |
| Product Code | KPT |
| CFR Regulation Number | 892.1360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-05-21 |
| Decision Date | 2007-06-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00859942006058 | K071396 | 000 |
| 00859942006041 | K071396 | 000 |
| 00859942006034 | K071396 | 000 |