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 |