The following data is part of a premarket notification filed by Sandoz Nutrition with the FDA for Compat Nasojejunal Feeding Tube.
Device ID | K961664 |
510k Number | K961664 |
Device Name: | COMPAT NASOJEJUNAL FEEDING TUBE |
Classification | Tubes, Gastrointestinal (and Accessories) |
Applicant | SANDOZ NUTRITION 1541 PARK PLACE BLVD. St. Louis Park, MN 55416 |
Contact | Robert J Lang |
Correspondent | Robert J Lang SANDOZ NUTRITION 1541 PARK PLACE BLVD. St. Louis Park, MN 55416 |
Product Code | KNT |
CFR Regulation Number | 876.5980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-04-30 |
Decision Date | 1996-10-04 |
Summary: | summary |