The following data is part of a premarket notification filed by Norwich Pharmacal Co. with the FDA for Vivonex Delivery System.
Device ID | K780415 |
510k Number | K780415 |
Device Name: | VIVONEX DELIVERY SYSTEM |
Classification | Tube, Feeding |
Applicant | NORWICH PHARMACAL CO. 803 N. Front St. Suite 3 McHenry, IL 60050 |
Product Code | FPD |
CFR Regulation Number | 876.5980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-03-14 |
Decision Date | 1978-04-10 |