The following data is part of a premarket notification filed by Nucletron Corporation with the FDA for Smit Sleeve.
| Device ID | K052228 |
| 510k Number | K052228 |
| Device Name: | SMIT SLEEVE |
| Classification | System, Applicator, Radionuclide, Remote-controlled |
| Applicant | NUCLETRON CORPORATION 8671 ROBERT FULTON DR. Columbia, MD 21046 -2133 |
| Contact | Lisa Dimmick |
| Correspondent | J.a. Van Vugt KEMA QUALITY B.V. 4377 COUNTY LINE ROAD Chalfont, PA 18914 |
| Product Code | JAQ |
| CFR Regulation Number | 892.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2005-08-16 |
| Decision Date | 2005-11-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08717213057258 | K052228 | 000 |
| 08717213057203 | K052228 | 000 |