The following data is part of a premarket notification filed by Cardinal Health with the FDA for Orwell Fluid Collection And Disposal System.
| Device ID | K080845 |
| 510k Number | K080845 |
| Device Name: | ORWELL FLUID COLLECTION AND DISPOSAL SYSTEM |
| Classification | Apparatus, Suction, Ward Use, Portable, Ac-powered |
| Applicant | Cardinal Health 1500 WAUKEGAN RD. BLDG. WM Mcgaw Park, IL 60085 |
| Contact | Lavenia Ford |
| Correspondent | Ned Devine UNDERWRITERS LABORATORIES, INC. 333 PFINGSTEN RD. Northbrook, IL 60062 |
| Product Code | JCX |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2008-03-26 |
| Decision Date | 2008-04-30 |
| Summary: | summary |