The following data is part of a premarket notification filed by Sandoz Nutrition with the FDA for Compat Enteral Delivery Systems.
| Device ID | K855098 | 
| 510k Number | K855098 | 
| Device Name: | COMPAT ENTERAL DELIVERY SYSTEMS | 
| Classification | Tubes, Gastrointestinal (and Accessories) | 
| Applicant | SANDOZ NUTRITION 5320 WEST TWENTY THIRD ST. P.O. BOX 370 Minneapolis, MN 55440 | 
| Contact | Longely Ph.d | 
| Correspondent | Longely Ph.d 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 | 1985-12-23 | 
| Decision Date | 1986-04-08 |