The following data is part of a premarket notification filed by Ackrad Laboratories with the FDA for Gastro Vage Set For Gastric Lavage.
| Device ID | K822228 |
| 510k Number | K822228 |
| Device Name: | GASTRO VAGE SET FOR GASTRIC LAVAGE |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | ACKRAD LABORATORIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-07-27 |
| Decision Date | 1982-09-09 |