The following data is part of a premarket notification filed by Hood Laboratories with the FDA for Cleaning Kit Care & Cleaning Of Tracheal T-tube.
| Device ID | K853419 |
| 510k Number | K853419 |
| Device Name: | CLEANING KIT CARE & CLEANING OF TRACHEAL T-TUBE |
| Classification | Tube, Tracheostomy (w/wo Connector) |
| Applicant | HOOD LABORATORIES 575 WASHINGTON ST. Pembroke, MA 02359 |
| Contact | Paul Vayo |
| Correspondent | Paul Vayo HOOD LABORATORIES 575 WASHINGTON ST. Pembroke, MA 02359 |
| Product Code | BTO |
| CFR Regulation Number | 868.5800 [🔎] |
| Decision | Substantially Equivalent - With Drug (SESD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-08-14 |
| Decision Date | 1985-12-06 |