The following data is part of a premarket notification filed by Churchill Corp. with the FDA for Blood Gas Sampler Kit.
| Device ID | K850958 |
| 510k Number | K850958 |
| Device Name: | BLOOD GAS SAMPLER KIT |
| Classification | Syringe, Piston |
| Applicant | CHURCHILL CORP. P.O. BOX 116 Pineville, PA 18946 |
| Contact | David W Evans |
| Correspondent | David W Evans CHURCHILL CORP. P.O. BOX 116 Pineville, PA 18946 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-03-08 |
| Decision Date | 1985-04-10 |