The following data is part of a premarket notification filed by Mallinckrodt Critical Care with the FDA for Uncuffed Laser Resisteant Tracheal Tube(tentative).
| Device ID | K862666 |
| 510k Number | K862666 |
| Device Name: | UNCUFFED LASER RESISTEANT TRACHEAL TUBE(TENTATIVE) |
| Classification | Tube, Tracheal (w/wo Connector) |
| Applicant | MALLINCKRODT CRITICAL CARE 73 QUAKER RD. Glens Falls, NY 12301 |
| Contact | Wiegert, Phd |
| Correspondent | Wiegert, Phd MALLINCKRODT CRITICAL CARE 73 QUAKER RD. Glens Falls, NY 12301 |
| Product Code | BTR |
| CFR Regulation Number | 868.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-07-14 |
| Decision Date | 1986-08-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30884522001353 | K862666 | 000 |
| 20884522001356 | K862666 | 000 |
| 30884522001377 | K862666 | 000 |
| 30884522001360 | K862666 | 000 |
| 20884522001370 | K862666 | 000 |
| 20884522001363 | K862666 | 000 |