The following data is part of a premarket notification filed by Rusch, Inc. with the FDA for Rusch Ultra Tracheoflex Tracheostomy Set, Cuffed, Sterile.
| Device ID | K955564 |
| 510k Number | K955564 |
| Device Name: | RUSCH ULTRA TRACHEOFLEX TRACHEOSTOMY SET, CUFFED, STERILE |
| Classification | Tube Tracheostomy And Tube Cuff |
| Applicant | RUSCH, INC. TALL PINES PARK Jaffrey, NH 03452 |
| Contact | Neil R Armstrong |
| Correspondent | Neil R Armstrong RUSCH, INC. TALL PINES PARK Jaffrey, NH 03452 |
| Product Code | JOH |
| CFR Regulation Number | 868.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-12-06 |
| Decision Date | 1996-06-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 44026704064678 | K955564 | 000 |
| 24026704009804 | K955564 | 000 |
| 44026704009815 | K955564 | 000 |
| 24026704009828 | K955564 | 000 |
| 44026704009839 | K955564 | 000 |
| 44026704009846 | K955564 | 000 |
| 44026704009853 | K955564 | 000 |
| 44026704009860 | K955564 | 000 |
| 24026704009873 | K955564 | 000 |
| 24026704009880 | K955564 | 000 |
| 24026704009897 | K955564 | 000 |
| 24026704009903 | K955564 | 000 |
| 44026704009792 | K955564 | 000 |