The following data is part of a premarket notification filed by Civatech Oncology, Inc. with the FDA for Civa Sheet Pd-103.
| Device ID | K140490 |
| 510k Number | K140490 |
| Device Name: | CIVA SHEET PD-103 |
| Classification | Source, Brachytherapy, Radionuclide |
| Applicant | CIVATECH ONCOLOGY, INC. 2600 MULLINIX MILL ROAD Mt. Airy, MD 21771 |
| Contact | Blix Winston |
| Correspondent | Blix Winston CIVATECH ONCOLOGY, INC. 2600 MULLINIX MILL ROAD Mt. Airy, MD 21771 |
| Product Code | KXK |
| CFR Regulation Number | 892.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-02-27 |
| Decision Date | 2014-08-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00869497000111 | K140490 | 000 |