The following data is part of a premarket notification filed by Texas Medical Products, Inc. with the FDA for Basin Pack.
| Device ID | K802538 |
| 510k Number | K802538 |
| Device Name: | BASIN PACK |
| Classification | Basin, Emesis |
| Applicant | TEXAS MEDICAL PRODUCTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FNY |
| CFR Regulation Number | 880.6730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-10-15 |
| Decision Date | 1980-10-31 |