The following data is part of a premarket notification filed by Hood Laboratories with the FDA for Hood Speaking Valve.
| Device ID | K897059 |
| 510k Number | K897059 |
| Device Name: | HOOD SPEAKING VALVE |
| Classification | Tube Tracheostomy And Tube Cuff |
| Applicant | HOOD LABORATORIES 575 WASHINGTON ST. Pembroke, MA 02359 |
| Contact | Lewis H Marten |
| Correspondent | Lewis H Marten HOOD LABORATORIES 575 WASHINGTON ST. Pembroke, MA 02359 |
| Product Code | JOH |
| CFR Regulation Number | 868.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-12-18 |
| Decision Date | 1990-03-12 |