The following data is part of a premarket notification filed by Sandoz Nutrition with the FDA for External Gastrostomy Tube Retainer.
| Device ID | K912575 |
| 510k Number | K912575 |
| Device Name: | EXTERNAL GASTROSTOMY TUBE RETAINER |
| Classification | Tube, Feeding |
| Applicant | SANDOZ NUTRITION 5320 WEST TWENTY THIRD ST. P.O. BOX 370 Minneapolis, MN 55440 |
| Contact | Robert J Lang |
| Correspondent | Robert J 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 (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-06-12 |
| Decision Date | 1991-11-21 |