The following data is part of a premarket notification filed by Dynarex Corp. with the FDA for Tracheostomy Care Kit.
| Device ID | K855130 |
| 510k Number | K855130 |
| Device Name: | TRACHEOSTOMY CARE KIT |
| Classification | Tube, Tracheostomy (w/wo Connector) |
| Applicant | DYNAREX CORP. ONE INTERNATIONAL BLVD. Brewster, NY 10509 |
| Contact | Marvin D Schattner |
| Correspondent | Marvin D Schattner DYNAREX CORP. ONE INTERNATIONAL BLVD. Brewster, NY 10509 |
| Product Code | BTO |
| CFR Regulation Number | 868.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-12-23 |
| Decision Date | 1986-03-04 |