The following data is part of a premarket notification filed by Esi with the FDA for Afterloading Gynecological Applicator.
| Device ID | K813230 |
| 510k Number | K813230 |
| Device Name: | AFTERLOADING GYNECOLOGICAL APPLICATOR |
| Classification | System, Applicator, Radionuclide, Manual |
| Applicant | ESI 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 | 1981-11-10 |
| Decision Date | 1981-12-29 |