The following data is part of a premarket notification filed by Hood Laboratories with the FDA for Hood Bifurcated T-tube.
| Device ID | K864533 |
| 510k Number | K864533 |
| Device Name: | HOOD BIFURCATED T-TUBE |
| Classification | Tube, Tracheal (w/wo Connector) |
| Applicant | HOOD LABORATORIES 575 WASHINGTON ST. Pembroke, MA 02359 |
| Contact | William Mccallum,iii |
| Correspondent | William Mccallum,iii HOOD LABORATORIES 575 WASHINGTON ST. Pembroke, MA 02359 |
| Product Code | BTR |
| CFR Regulation Number | 868.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-11-18 |
| Decision Date | 1987-03-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00815347022567 | K864533 | 000 |
| 00815347022550 | K864533 | 000 |
| 00815347022543 | K864533 | 000 |
| 00815347022536 | K864533 | 000 |
| 00815347022529 | K864533 | 000 |
| 00815347022512 | K864533 | 000 |
| 00815347022505 | K864533 | 000 |
| 00815347022499 | K864533 | 000 |
| 00815347022482 | K864533 | 000 |