The following data is part of a premarket notification filed by Excel Health Care Products with the FDA for Tracheostomy Care Kit.
| Device ID | K850456 |
| 510k Number | K850456 |
| Device Name: | TRACHEOSTOMY CARE KIT |
| Classification | Tube, Tracheostomy (w/wo Connector) |
| Applicant | EXCEL HEALTH CARE PRODUCTS 5001 HADLEY RD. South Plainfield, NJ 07080 |
| Contact | David Catlin |
| Correspondent | David Catlin EXCEL HEALTH CARE PRODUCTS 5001 HADLEY RD. South Plainfield, NJ 07080 |
| Product Code | BTO |
| CFR Regulation Number | 868.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-02-06 |
| Decision Date | 1985-03-11 |