The following data is part of a premarket notification filed by Omnitron Intl., Inc. with the FDA for Ir-192 Implant -- Modification.
Device ID | K923130 |
510k Number | K923130 |
Device Name: | IR-192 IMPLANT -- MODIFICATION |
Classification | Source, Brachytherapy, Radionuclide |
Applicant | OMNITRON INTL., INC. P.O. BOX 5247 3409 WEST PRIE LAKE ROAD Lajke Charles, LA 70606 |
Product Code | KXK |
CFR Regulation Number | 892.5730 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-06-25 |
Decision Date | 1992-09-21 |