The following data is part of a premarket notification filed by American V. Mueller with the FDA for V. Mueller Pneumo-intestinal 15 Vascular & 30 Stap.
| Device ID | K854568 |
| 510k Number | K854568 |
| Device Name: | V. MUELLER PNEUMO-INTESTINAL 15 VASCULAR & 30 STAP |
| Classification | Applier, Staple, Surgical, |
| 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 | GEF |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-11-14 |
| Decision Date | 1985-12-02 |