The following data is part of a premarket notification filed by American Heyer Schulte with the FDA for Heyer-schulte Afterloading Catheter.
| Device ID | K832738 |
| 510k Number | K832738 |
| Device Name: | HEYER-SCHULTE AFTERLOADING CATHETER |
| Classification | System, Applicator, Radionuclide, Manual |
| Applicant | AMERICAN HEYER SCHULTE 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | IWJ |
| CFR Regulation Number | 892.5650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-08-12 |
| Decision Date | 1983-09-29 |