The following data is part of a premarket notification filed by Hood Laboratories with the FDA for Laryngeal.
| Device ID | K853726 |
| 510k Number | K853726 |
| Device Name: | LARYNGEAL |
| Classification | Prosthesis, Larynx (stents And Keels) |
| Applicant | HOOD LABORATORIES 575 WASHINGTON ST. Pembroke, MA 02359 |
| Contact | Bruce Barber |
| Correspondent | Bruce Barber HOOD LABORATORIES 575 WASHINGTON ST. Pembroke, MA 02359 |
| Product Code | FWN |
| CFR Regulation Number | 874.3620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-09-06 |
| Decision Date | 1986-03-12 |