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 |