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 |