The following data is part of a premarket notification filed by Sandoz Nutrition with the FDA for Vinyl Bag W/pump Administration Set.
Device ID | K893540 |
510k Number | K893540 |
Device Name: | VINYL BAG W/PUMP ADMINISTRATION SET |
Classification | Tubes, Gastrointestinal (and Accessories) |
Applicant | SANDOZ NUTRITION 5320 WEST TWENTY THIRD ST. P.O. BOX 370 Minneapolis, MN 55440 |
Contact | Egberg, Phd |
Correspondent | Egberg, Phd SANDOZ NUTRITION 5320 WEST TWENTY THIRD ST. P.O. BOX 370 Minneapolis, MN 55440 |
Product Code | KNT |
CFR Regulation Number | 876.5980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-05-08 |
Decision Date | 1989-10-17 |