The following data is part of a premarket notification filed by Loseff Medical Designers, Ltd. with the FDA for Balloon Retention Chest Catheter.
| Device ID | K802025 |
| 510k Number | K802025 |
| Device Name: | BALLOON RETENTION CHEST CATHETER |
| Classification | Catheter, Balloon Type |
| Applicant | LOSEFF MEDICAL DESIGNERS, LTD. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GBA |
| CFR Regulation Number | 878.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-08-20 |
| Decision Date | 1980-09-26 |