The following data is part of a premarket notification filed by Amersham Corp. with the FDA for Handling & Cutting Device For Iridium-192 Wire Pin.
| Device ID | K890191 |
| 510k Number | K890191 |
| Device Name: | HANDLING & CUTTING DEVICE FOR IRIDIUM-192 WIRE PIN |
| Classification | System, Applicator, Radionuclide, Manual |
| 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 | IWJ |
| CFR Regulation Number | 892.5650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-01-18 |
| Decision Date | 1989-02-06 |