The following data is part of a premarket notification filed by Churchill Corp. with the FDA for Churchill 3-way Stopcock Set.
| Device ID | K854348 |
| 510k Number | K854348 |
| Device Name: | CHURCHILL 3-WAY STOPCOCK SET |
| Classification | Stopcock, I.v. Set |
| 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 | FMG |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-10-29 |
| Decision Date | 1985-11-08 |