The following data is part of a premarket notification filed by Mentor Corp. with the FDA for Mentor Isoloader Automatic Needle Loading System And Physics Workstation For Brachytherapy.
| Device ID | K011493 |
| 510k Number | K011493 |
| Device Name: | MENTOR ISOLOADER AUTOMATIC NEEDLE LOADING SYSTEM AND PHYSICS WORKSTATION FOR BRACHYTHERAPY |
| Classification | Calibrator, Dose, Radionuclide |
| Applicant | MENTOR CORP. 9727 VALLEY VIEW RD. Eden Prairie, MN 55344 |
| Contact | George Hoedeman |
| Correspondent | George Hoedeman MENTOR CORP. 9727 VALLEY VIEW RD. Eden Prairie, MN 55344 |
| Product Code | KPT |
| CFR Regulation Number | 892.1360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-05-15 |
| Decision Date | 2002-10-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00813787020761 | K011493 | 000 |
| 00813787020754 | K011493 | 000 |
| 00813787020297 | K011493 | 000 |
| 00813787020280 | K011493 | 000 |