The following data is part of a premarket notification filed by Rusch, Inc. with the FDA for Rusch Safety Clear Plus Cuffed W/murphy Eye.
| Device ID | K925505 |
| 510k Number | K925505 |
| Device Name: | RUSCH SAFETY CLEAR PLUS CUFFED W/MURPHY EYE |
| Classification | Tube, Tracheal (w/wo Connector) |
| Applicant | RUSCH, INC. TALL PINES PARK Jaffrey, NH 03452 |
| Contact | Richard T Lykins |
| Correspondent | Richard T Lykins RUSCH, INC. TALL PINES PARK Jaffrey, NH 03452 |
| Product Code | BTR |
| CFR Regulation Number | 868.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-10-30 |
| Decision Date | 1993-09-02 |