The following data is part of a premarket notification filed by Amersham Corp. with the FDA for Cesium-137 Microseed Source Train Assembly/shield.
| Device ID | K894409 |
| 510k Number | K894409 |
| Device Name: | CESIUM-137 MICROSEED SOURCE TRAIN ASSEMBLY/SHIELD |
| Classification | Source, Wire, Iridium, Radioactive |
| Applicant | AMERSHAM CORP. 2636 SOUTH CLEARBROOK DR. Arlington Heights, IL 60005 |
| Contact | Frank J Lyman |
| Correspondent | Frank J Lyman AMERSHAM CORP. 2636 SOUTH CLEARBROOK DR. Arlington Heights, IL 60005 |
| Product Code | IWA |
| CFR Regulation Number | 892.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-17 |
| Decision Date | 1989-09-29 |