The following data is part of a premarket notification filed by Churchill Corp. with the FDA for Enteral Bag/set.
| Device ID | K880051 |
| 510k Number | K880051 |
| Device Name: | ENTERAL BAG/SET |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | CHURCHILL CORP. ONE SUMMIT SQUARE ROUTE 413 & DOUBLEWOODS ROAD Langhorne, PA 19047 |
| Contact | David W Evans |
| Correspondent | David W Evans CHURCHILL CORP. ONE SUMMIT SQUARE ROUTE 413 & DOUBLEWOODS ROAD Langhorne, PA 19047 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-01-06 |
| Decision Date | 1988-04-14 |