The following data is part of a premarket notification filed by Sandoz Nutrition with the FDA for Compat Gastrostomy/jejunostomy Feeding Tube Kit(088000).
| Device ID | K965087 |
| 510k Number | K965087 |
| Device Name: | COMPAT GASTROSTOMY/JEJUNOSTOMY FEEDING TUBE KIT(088000) |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | SANDOZ NUTRITION P.O. BOX 370 Minneapolis, MN 55440 |
| Contact | Robert J Lang |
| Correspondent | Robert J Lang SANDOZ NUTRITION P.O. BOX 370 Minneapolis, MN 55440 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-12-19 |
| Decision Date | 1997-03-18 |
| Summary: | summary |