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 |