The following data is part of a premarket notification filed by Churchill Medical Systems, Inc. with the FDA for Churchill Medical Dual Chamber Empty Container.
| Device ID | K041038 |
| 510k Number | K041038 |
| Device Name: | CHURCHILL MEDICAL DUAL CHAMBER EMPTY CONTAINER |
| Classification | Container, I.v. |
| Applicant | CHURCHILL MEDICAL SYSTEMS, INC. 87 VENTURE DR. ENTERPRISE PARK Dover, NH 03820 |
| Contact | Keith Paluch |
| Correspondent | Keith Paluch CHURCHILL MEDICAL SYSTEMS, INC. 87 VENTURE DR. ENTERPRISE PARK Dover, NH 03820 |
| Product Code | KPE |
| CFR Regulation Number | 880.5025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-04-22 |
| Decision Date | 2004-12-21 |
| Summary: | summary |