The following data is part of a premarket notification filed by Nucletron Corporation with the FDA for Nucletron Comfort Catheter System, Model 189.007.
| Device ID | K032372 |
| 510k Number | K032372 |
| Device Name: | NUCLETRON COMFORT CATHETER SYSTEM, MODEL 189.007 |
| Classification | System, Applicator, Radionuclide, Remote-controlled |
| Applicant | NUCLETRON CORPORATION 7080 COLUMBIA GATEWAY DR. Columbia, MD 21046 -2133 |
| Contact | Lisa Dimmick |
| Correspondent | Peter N Ruys N.V. KEMA P.O. BOX 9035 6800 ET ARNHEM Arnhem, NL |
| Product Code | JAQ |
| CFR Regulation Number | 892.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2003-08-01 |
| Decision Date | 2003-08-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08717213055278 | K032372 | 000 |
| 08717213054240 | K032372 | 000 |
| 08717213054301 | K032372 | 000 |
| 08717213054295 | K032372 | 000 |
| 08717213054288 | K032372 | 000 |
| 08717213054271 | K032372 | 000 |
| 08717213054264 | K032372 | 000 |
| 08717213054257 | K032372 | 000 |
| 08717213054233 | K032372 | 000 |
| 08717213054226 | K032372 | 000 |
| 08717213055490 | K032372 | 000 |
| 08717213055483 | K032372 | 000 |
| 08717213055445 | K032372 | 000 |
| 08717213055452 | K032372 | 000 |
| 08717213054172 | K032372 | 000 |
| 08717213055261 | K032372 | 000 |
| 08717213055247 | K032372 | 000 |
| 08717213055223 | K032372 | 000 |
| 08717213054219 | K032372 | 000 |
| 08717213054202 | K032372 | 000 |
| 08717213054189 | K032372 | 000 |
| 08717213054196 | K032372 | 000 |
| 08717213054158 | K032372 | 000 |
| 08717213055230 | K032372 | 000 |
| 08717213054165 | K032372 | 000 |
| 08717213055254 | K032372 | 000 |
| 08717213055476 | K032372 | 000 |