The following data is part of a premarket notification filed by Mallinckrodt Medical with the FDA for Hi-lo Evac And Evac Ii Endotracheal Tubes.
| Device ID | K965132 |
| 510k Number | K965132 |
| Device Name: | HI-LO EVAC AND EVAC II ENDOTRACHEAL TUBES |
| Classification | Tube, Tracheal (w/wo Connector) |
| Applicant | MALLINCKRODT MEDICAL 675 MCDONNELL BLVD. P.O. BOX 5840 St. Louis, MO 63134 |
| Contact | Michael B Schoeck |
| Correspondent | Michael B Schoeck MALLINCKRODT MEDICAL 675 MCDONNELL BLVD. P.O. BOX 5840 St. Louis, MO 63134 |
| Product Code | BTR |
| CFR Regulation Number | 868.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-12-23 |
| Decision Date | 1997-03-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 40884522005730 | K965132 | 000 |
| 60884522000180 | K965132 | 000 |
| 50884522000176 | K965132 | 000 |
| 10884522005739 | K965132 | 000 |
| 10884522005722 | K965132 | 000 |
| 10884522005715 | K965132 | 000 |
| 10884522005692 | K965132 | 000 |
| 10884522005685 | K965132 | 000 |
| 10884522000499 | K965132 | 000 |
| 10884522000475 | K965132 | 000 |
| 20884522000465 | K965132 | 000 |
| 20884522000458 | K965132 | 000 |
| 30884522005702 | K965132 | 000 |
| 10889942274512 | K965132 | 000 |
| 30884522000516 | K965132 | 000 |
| 20884522000502 | K965132 | 000 |
| 30884522000486 | K965132 | 000 |
| 60884522000197 | K965132 | 000 |
| 60884522000203 | K965132 | 000 |
| 50884522000213 | K965132 | 000 |
| 50884522005720 | K965132 | 000 |
| 50884522005713 | K965132 | 000 |
| 40884522005709 | K965132 | 000 |
| 50884522005690 | K965132 | 000 |
| 40884522005686 | K965132 | 000 |
| 20884522000786 | K965132 | 000 |
| 40884522000513 | K965132 | 000 |
| 50884522000503 | K965132 | 000 |
| 50884522000497 | K965132 | 000 |
| 40884522000483 | K965132 | 000 |
| 50884522000473 | K965132 | 000 |
| 40884522000469 | K965132 | 000 |
| 40884522000452 | K965132 | 000 |
| 50884522000442 | K965132 | 000 |
| 40884522000780 | K965132 | 000 |
| 50884522000220 | K965132 | 000 |
| 20884522000441 | K965132 | 000 |