The following data is part of a premarket notification filed by Omnitron Intl., Inc. with the FDA for Omnicath Implanted Catheter And Depot.
| Device ID | K911775 |
| 510k Number | K911775 |
| Device Name: | OMNICATH IMPLANTED CATHETER AND DEPOT |
| Classification | Source, Brachytherapy, Radionuclide |
| Applicant | OMNITRON INTL., INC. 8990 KIRBY, SUITE 200 Houston, TX 77054 |
| Contact | Lisa S Jones |
| Correspondent | Lisa S Jones OMNITRON INTL., INC. 8990 KIRBY, SUITE 200 Houston, TX 77054 |
| Product Code | KXK |
| CFR Regulation Number | 892.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-04-01 |
| Decision Date | 1991-05-08 |