The following data is part of a premarket notification filed by Hood Laboratories with the FDA for Hood Pediatric Tracheostomy Tube.
| Device ID | K893866 |
| 510k Number | K893866 |
| Device Name: | HOOD PEDIATRIC TRACHEOSTOMY TUBE |
| Classification | Tube, Tracheostomy (w/wo Connector) |
| Applicant | HOOD LABORATORIES 575 WASHINGTON ST. Pembroke, MA 02359 |
| Contact | Lewis Marten |
| Correspondent | Lewis 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 | 1989-05-26 |
| Decision Date | 1989-08-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04035324032372 | K893866 | 000 |
| 04035324032365 | K893866 | 000 |