The following data is part of a premarket notification filed by Clinical Resources, Inc. with the FDA for Tracheostomy Care Kit.
| Device ID | K941470 |
| 510k Number | K941470 |
| Device Name: | TRACHEOSTOMY CARE KIT |
| Classification | Tube, Tracheostomy (w/wo Connector) |
| 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 | BTO |
| CFR Regulation Number | 868.5800 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-28 |
| Decision Date | 1995-02-14 |