The following data is part of a premarket notification filed by Nucletron Corp. with the FDA for Standard Ct/mr Applicator Set,ring Ct/mr Applicator Set, Vaginal Ct/mr Applicator Set, Fletcher Williamson Applicator Se.
| Device ID | K983341 |
| 510k Number | K983341 |
| Device Name: | STANDARD CT/MR APPLICATOR SET,RING CT/MR APPLICATOR SET, VAGINAL CT/MR APPLICATOR SET, FLETCHER WILLIAMSON APPLICATOR SE |
| Classification | System, Applicator, Radionuclide, Remote-controlled |
| Applicant | NUCLETRON CORP. 7080 COLUMBIA GATEWAY DR. Columbia, MD 21046 |
| Contact | Ralph E Shuping |
| Correspondent | Ralph E Shuping NUCLETRON CORP. 7080 COLUMBIA GATEWAY DR. Columbia, MD 21046 |
| Product Code | JAQ |
| CFR Regulation Number | 892.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-09-23 |
| Decision Date | 1999-04-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08717213007789 | K983341 | 000 |
| 08717213013995 | K983341 | 000 |
| 08717213009684 | K983341 | 000 |
| 08717213053137 | K983341 | 000 |