The following data is part of a premarket notification filed by Paco Research Corp. with the FDA for Tracheostomy Care Tray.
| Device ID | K850445 |
| 510k Number | K850445 |
| Device Name: | TRACHEOSTOMY CARE TRAY |
| Classification | Tube, Tracheostomy (w/wo Connector) |
| Applicant | PACO RESEARCH CORP. ELLIS PHARMACEUTICAL CONSULTIN 913 STATE ROAD Princeton, NJ 08540 |
| Contact | Levi Ellis |
| Correspondent | Levi Ellis PACO RESEARCH CORP. ELLIS PHARMACEUTICAL CONSULTIN 913 STATE ROAD Princeton, NJ 08540 |
| Product Code | BTO |
| CFR Regulation Number | 868.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-02-05 |
| Decision Date | 1985-03-11 |