The following data is part of a premarket notification filed by Clinical Resources, Inc. with the FDA for Central Line Dressing Change Tray.
| Device ID | K941471 |
| 510k Number | K941471 |
| Device Name: | CENTRAL LINE DRESSING CHANGE TRAY |
| Classification | Wrap, Sterilization |
| Applicant | CLINICAL RESOURCES, INC. 825A TOLLGATE RD. Elgin, IL 60123 |
| Contact | David Insco |
| Correspondent | David Insco CLINICAL RESOURCES, INC. 825A TOLLGATE RD. Elgin, IL 60123 |
| Product Code | FRG |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-28 |
| Decision Date | 1994-05-12 |