The following data is part of a premarket notification filed by Omnitron Intl., Inc. with the FDA for Omnitron Remote Controlled Radionuclide Applicator.
| Device ID | K881665 |
| 510k Number | K881665 |
| Device Name: | OMNITRON REMOTE CONTROLLED RADIONUCLIDE APPLICATOR |
| Classification | System, Applicator, Radionuclide, Remote-controlled |
| Applicant | OMNITRON INTL., INC. 3839 ULLOA ST. SUITE 100 New Orleans, LA 70119 |
| Contact | Kathleen W Judge |
| Correspondent | Kathleen W Judge OMNITRON INTL., INC. 3839 ULLOA ST. SUITE 100 New Orleans, LA 70119 |
| Product Code | JAQ |
| CFR Regulation Number | 892.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-04-18 |
| Decision Date | 1988-08-11 |