The following data is part of a premarket notification filed by Hood Laboratories with the FDA for The Hood Life Saver.
| Device ID | K853511 |
| 510k Number | K853511 |
| Device Name: | THE HOOD LIFE SAVER |
| Classification | Tube, Tracheostomy (w/wo Connector) |
| Applicant | HOOD LABORATORIES 575 WASHINGTON ST. Pembroke, MA 02359 |
| Contact | Bruce Barbar |
| Correspondent | Bruce Barbar HOOD LABORATORIES 575 WASHINGTON ST. Pembroke, MA 02359 |
| Product Code | BTO |
| CFR Regulation Number | 868.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-08-21 |
| Decision Date | 1985-12-19 |