The following data is part of a premarket notification filed by Rusch, Inc. with the FDA for Rusch Lasertubus/rusch Laser Resistant Cuffed With Murphy Eye.
| Device ID | K935842 |
| 510k Number | K935842 |
| Device Name: | RUSCH LASERTUBUS/RUSCH LASER RESISTANT CUFFED WITH MURPHY EYE |
| Classification | Tube, Tracheal (w/wo Connector) |
| Applicant | RUSCH, INC. 2450 MEADOWBROOK PKWY. Duluth, GA 30096 |
| Contact | Karenann J Brozowski |
| Correspondent | Karenann J Brozowski RUSCH, INC. 2450 MEADOWBROOK PKWY. Duluth, GA 30096 |
| Product Code | BTR |
| CFR Regulation Number | 868.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-12-07 |
| Decision Date | 1995-05-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 24026704002683 | K935842 | 000 |
| 24026704002676 | K935842 | 000 |
| 24026704002669 | K935842 | 000 |
| 24026704002652 | K935842 | 000 |
| 44026704002649 | K935842 | 000 |