The following data is part of a premarket notification filed by Hood Laboratories with the FDA for Silicone Laryngeal Stent.
| Device ID | K884810 |
| 510k Number | K884810 |
| Device Name: | SILICONE LARYNGEAL STENT |
| Classification | Prosthesis, Larynx (stents And Keels) |
| 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 | FWN |
| CFR Regulation Number | 874.3620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-11-17 |
| Decision Date | 1989-05-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00815347023335 | K884810 | 000 |
| 00815347023328 | K884810 | 000 |