The following data is part of a premarket notification filed by Civatech Oncology, Inc. with the FDA for Civastring Pd-103.
| Device ID | K082159 |
| 510k Number | K082159 |
| Device Name: | CIVASTRING PD-103 |
| Classification | Source, Brachytherapy, Radionuclide |
| Applicant | CIVATECH ONCOLOGY, INC. 1317 BUCHANAN DR. Mebane, NC 27302 |
| Contact | Lois V Smart |
| Correspondent | Lois V Smart CIVATECH ONCOLOGY, INC. 1317 BUCHANAN DR. Mebane, NC 27302 |
| Product Code | KXK |
| CFR Regulation Number | 892.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-07-31 |
| Decision Date | 2008-09-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00869497000104 | K082159 | 000 |