The following data is part of a premarket notification filed by Churchill Corp. with the FDA for Modified Hc-417 Bag To Bag & Hc-418 Bottle To Bag.
| Device ID | K861434 |
| 510k Number | K861434 |
| Device Name: | MODIFIED HC-417 BAG TO BAG & HC-418 BOTTLE TO BAG |
| Classification | Set, I.v. Fluid Transfer |
| 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 | LHI |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-04-17 |
| Decision Date | 1986-05-01 |