The following data is part of a premarket notification filed by Omnitron Intl., Inc. with the FDA for Omnitron Gyn Applicator System.
Device ID | K913908 |
510k Number | K913908 |
Device Name: | OMNITRON GYN APPLICATOR SYSTEM |
Classification | System, Applicator, Radionuclide, Remote-controlled |
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 | JAQ |
CFR Regulation Number | 892.5700 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-08-30 |
Decision Date | 1992-03-06 |