The following data is part of a premarket notification filed by Hood Laboratories with the FDA for Hood Tracheal Stoma Button.
| Device ID | K882430 |
| 510k Number | K882430 |
| Device Name: | HOOD TRACHEAL STOMA BUTTON |
| Classification | Tube, Tracheostomy (w/wo Connector) |
| 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 | BTO |
| CFR Regulation Number | 868.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-06-14 |
| Decision Date | 1988-06-28 |