The following data is part of a premarket notification filed by Nucletron Corporation with the FDA for Utrecht Interstitial Fletcher Ct/mr Applicator Set, Model 110.270, Interstitial Ring Ct/mr Applicator Set,model 110.330,.
| Device ID | K091154 |
| 510k Number | K091154 |
| Device Name: | UTRECHT INTERSTITIAL FLETCHER CT/MR APPLICATOR SET, MODEL 110.270, INTERSTITIAL RING CT/MR APPLICATOR SET,MODEL 110.330, |
| Classification | System, Applicator, Radionuclide, Remote-controlled |
| Applicant | NUCLETRON CORPORATION 8671 ROBERT FULTON DR. Columbia, MD 21046 |
| Contact | Elaina Colby |
| Correspondent | Elaina Colby NUCLETRON CORPORATION 8671 ROBERT FULTON DR. Columbia, MD 21046 |
| Product Code | JAQ |
| CFR Regulation Number | 892.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-04-21 |
| Decision Date | 2009-05-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08717213056947 | K091154 | 000 |