The following data is part of a premarket notification filed by American V. Mueller with the FDA for Gauderer Gastrostomy Button.
| Device ID | K843392 |
| 510k Number | K843392 |
| Device Name: | GAUDERER GASTROSTOMY BUTTON |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | AMERICAN V. MUELLER 6600 W. TOUHY Chicago, IL 60648 |
| Contact | Matthew Nowland |
| Correspondent | Matthew Nowland AMERICAN V. MUELLER 6600 W. TOUHY Chicago, IL 60648 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-08-29 |
| Decision Date | 1984-10-11 |