The following data is part of a premarket notification filed by Novartis Nutrition Corp. with the FDA for Novartis Compat Surgical Gastrostomy Jejunostomy Feeding Tube Kit.
| Device ID | K071191 |
| 510k Number | K071191 |
| Device Name: | NOVARTIS COMPAT SURGICAL GASTROSTOMY JEJUNOSTOMY FEEDING TUBE KIT |
| Classification | Tube, Feeding |
| Applicant | NOVARTIS NUTRITION CORP. 1541 PARK PLACE BLVD. St. Louis Park, MN 55416 |
| Correspondent | Laura Danielson TUV SUD AMERICA INC. 1775 OLD HIGHWAY 8 NW New Brighton, MN 55112 -1891 |
| Product Code | FPD |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2007-04-30 |
| Decision Date | 2007-07-23 |
| Summary: | summary |