The following data is part of a premarket notification filed by Sandoz Nutrition with the FDA for Nasogastric Feeding Tube Kits.
Device ID | K915439 |
510k Number | K915439 |
Device Name: | NASOGASTRIC FEEDING TUBE KITS |
Classification | Tube, Feeding |
Applicant | SANDOZ NUTRITION 5320 WEST TWENTY THIRD ST. P.O. BOX 370 Minneapolis, MN 55440 |
Contact | Robert Lang |
Correspondent | Robert 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 | 1991-12-02 |
Decision Date | 1992-02-25 |