The following data is part of a premarket notification filed by Norwich Eaton Pharmaceuticals, Inc. with the FDA for Vivonex Mass Gastrastomy Tube.
| Device ID | K822516 |
| 510k Number | K822516 |
| Device Name: | VIVONEX MASS GASTRASTOMY TUBE |
| Classification | Fraction V, Antigen, Antiserum, Control |
| Applicant | NORWICH EATON PHARMACEUTICALS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KHT |
| CFR Regulation Number | 866.5370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-08-20 |
| Decision Date | 1982-09-07 |