The following data is part of a premarket notification filed by Sandoz Nutrition with the FDA for Nasojejunal Feeding Tube W/gastric Drainage.
Device ID | K913407 |
510k Number | K913407 |
Device Name: | NASOJEJUNAL FEEDING TUBE W/GASTRIC DRAINAGE |
Classification | Tube, Feeding |
Applicant | SANDOZ NUTRITION 5320 WEST TWENTY THIRD ST. P.O. BOX 370 Minneapolis, MN 55440 |
Contact | Robert J Lang |
Correspondent | Robert J Lang SANDOZ NUTRITION 5320 WEST TWENTY THIRD ST. P.O. BOX 370 Minneapolis, MN 55440 |
Product Code | FPD |
CFR Regulation Number | 876.5980 [🔎] |
Decision | Substantially Equivalent - Kit (SESK) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-07-30 |
Decision Date | 1992-02-25 |