The following data is part of a premarket notification filed by Schiff & Co. with the FDA for Nutrisafe Enteral Feeding Tube.
Device ID | K981629 |
510k Number | K981629 |
Device Name: | NUTRISAFE ENTERAL FEEDING TUBE |
Classification | Tube, Feeding |
Applicant | SCHIFF & CO. 1129 BLOOMFIELD AVE. West Caldwell, NJ 07006 |
Contact | Anne M Cesario |
Correspondent | Anne M Cesario SCHIFF & CO. 1129 BLOOMFIELD AVE. West Caldwell, NJ 07006 |
Product Code | FPD |
CFR Regulation Number | 876.5980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-05-07 |
Decision Date | 1999-02-04 |