The following data is part of a premarket notification filed by Comecer Netherlands B.v. with the FDA for Veenstra Instruments Vdc-506 Dose Calibrator.
| Device ID | K142325 |
| 510k Number | K142325 |
| Device Name: | Veenstra Instruments VDC-506 Dose Calibrator |
| Classification | Calibrator, Dose, Radionuclide |
| Applicant | Comecer Netherlands B.v. Madam Curieweg 1 Joure, NL 8501 Xc |
| Contact | Gert Jan Klok |
| Correspondent | Thomas Kroenke Speed To Market, Inc. PO Box 3018 Nederland, CO 80466 |
| Product Code | KPT |
| CFR Regulation Number | 892.1360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-20 |
| Decision Date | 2014-09-18 |
| Summary: | summary |