The following data is part of a premarket notification filed by Omnitron Intl., Inc. with the FDA for Omnitron Needle Applicators 18 And 21 Gauge.
| Device ID | K920431 |
| 510k Number | K920431 |
| Device Name: | OMNITRON NEEDLE APPLICATORS 18 AND 21 GAUGE |
| 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 | 1992-02-03 |
| Decision Date | 1992-05-29 |