The following data is part of a premarket notification filed by Nucletron Corporation with the FDA for Proguide Needle Set.
| Device ID | K060349 |
| 510k Number | K060349 |
| Device Name: | PROGUIDE NEEDLE SET |
| Classification | System, Applicator, Radionuclide, Remote-controlled |
| Applicant | NUCLETRON CORPORATION 8671 ROBERT FULTON DR. Columbia, MD 21046 -2133 |
| Contact | Lisa Dimmick |
| Correspondent | Lisa Dimmick NUCLETRON CORPORATION 8671 ROBERT FULTON DR. Columbia, MD 21046 -2133 |
| Product Code | JAQ |
| CFR Regulation Number | 892.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-02-10 |
| Decision Date | 2006-03-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08717213054486 | K060349 | 000 |
| 08717213054530 | K060349 | 000 |
| 08717213054592 | K060349 | 000 |
| 08717213054554 | K060349 | 000 |
| 08717213054523 | K060349 | 000 |
| 08717213053847 | K060349 | 000 |
| 08717213053809 | K060349 | 000 |
| 08717213053793 | K060349 | 000 |
| 08717213052932 | K060349 | 000 |
| 08717213025073 | K060349 | 000 |
| 08717213025110 | K060349 | 000 |
| 08717213025011 | K060349 | 000 |
| 08717213054578 | K060349 | 000 |
| 08717213054615 | K060349 | 000 |
| 08717213054493 | K060349 | 000 |
| 08717213054707 | K060349 | 000 |
| 08717213054691 | K060349 | 000 |
| 08717213054684 | K060349 | 000 |
| 08717213054677 | K060349 | 000 |
| 08717213054660 | K060349 | 000 |
| 08717213054653 | K060349 | 000 |
| 08717213054646 | K060349 | 000 |
| 08717213054639 | K060349 | 000 |
| 08717213054622 | K060349 | 000 |
| 08717213054479 | K060349 | 000 |
| 00860005821204 | K060349 | 000 |