The following data is part of a premarket notification filed by Mallinckrodt Medical with the FDA for Rae(r) Ii Tracheal Tube.
| Device ID | K932280 |
| 510k Number | K932280 |
| Device Name: | RAE(R) II TRACHEAL TUBE |
| Classification | Tube, Tracheal (w/wo Connector) |
| Applicant | MALLINCKRODT MEDICAL R.D. #1 BOX 1173 HOOK ROAD Argyle, NY 12809 |
| Contact | Lynn C Stimpson |
| Correspondent | Lynn C Stimpson MALLINCKRODT MEDICAL R.D. #1 BOX 1173 HOOK ROAD Argyle, NY 12809 |
| Product Code | BTR |
| CFR Regulation Number | 868.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-05-12 |
| Decision Date | 1993-07-08 |