The following data is part of a premarket notification filed by Churchill Corp. with the FDA for Churchill-he Vented Iv Set.
| Device ID | K854636 |
| 510k Number | K854636 |
| Device Name: | CHURCHILL-HE VENTED IV SET |
| Classification | Set, Administration, Intravascular |
| 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 | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-11-19 |
| Decision Date | 1985-12-10 |