The following data is part of a premarket notification filed by Nucletron Corp. with the FDA for Freiburg Flap Applicator Set, Part Number 089.095.
| Device ID | K983338 |
| 510k Number | K983338 |
| Device Name: | FREIBURG FLAP APPLICATOR SET, PART NUMBER 089.095 |
| 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 | 1999-04-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08717213060722 | K983338 | 000 |