The following data is part of a premarket notification filed by Amersham Corp. with the FDA for Cesium-137 Afterloading System /gyn.bra..
| Device ID | K800320 |
| 510k Number | K800320 |
| Device Name: | CESIUM-137 AFTERLOADING SYSTEM /GYN.BRA. |
| Classification | System, Applicator, Radionuclide, Manual |
| Applicant | AMERSHAM CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | IWJ |
| CFR Regulation Number | 892.5650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-02-12 |
| Decision Date | 1980-03-25 |