The following data is part of a premarket notification filed by Omnitron Intl., Inc. with the FDA for Pulmocath Intrabronchial Catheter.
| Device ID | K901615 |
| 510k Number | K901615 |
| Device Name: | PULMOCATH INTRABRONCHIAL CATHETER |
| Classification | System, Applicator, Radionuclide, Remote-controlled |
| Applicant | OMNITRON INTL., INC. P.O. BOX 5247 3409 WEST PRIE LAKE ROAD Lajke Charles, LA 70606 |
| Contact | Sam F Liprie |
| Correspondent | Sam F Liprie OMNITRON INTL., INC. P.O. BOX 5247 3409 WEST PRIE LAKE ROAD Lajke Charles, LA 70606 |
| Product Code | JAQ |
| CFR Regulation Number | 892.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-04-06 |
| Decision Date | 1992-11-27 |