The following data is part of a premarket notification filed by Acumed Instruments Corp. with the FDA for Gastric Lavage Kit-disposable.
| Device ID | K791400 |
| 510k Number | K791400 |
| Device Name: | GASTRIC LAVAGE KIT-DISPOSABLE |
| Classification | Catheter, Continuous Irrigation |
| Applicant | ACUMED INSTRUMENTS CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GBQ |
| CFR Regulation Number | 878.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-07-16 |
| Decision Date | 1979-08-16 |