The following data is part of a premarket notification filed by Rusch Intl. with the FDA for Rusch Ultra Tracheoflex Fenestrated Kit Cuffed,uncuffed/ Rusch Tracheoflex Tracheostomy Kit Uncuffed Sterile.
| Device ID | K964056 |
| 510k Number | K964056 |
| Device Name: | RUSCH ULTRA TRACHEOFLEX FENESTRATED KIT CUFFED,UNCUFFED/ RUSCH TRACHEOFLEX TRACHEOSTOMY KIT UNCUFFED STERILE |
| Classification | Tube Tracheostomy And Tube Cuff |
| Applicant | RUSCH INTL. TALL PINES PARK Jaffrey, NH 03452 |
| Contact | Neil R Armstrong |
| Correspondent | Neil R Armstrong RUSCH INTL. 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 | 1996-10-09 |
| Decision Date | 1997-10-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 24026704010442 | K964056 | 000 |
| 24026704010343 | K964056 | 000 |
| 24026704010350 | K964056 | 000 |
| 24026704010367 | K964056 | 000 |
| 24026704010374 | K964056 | 000 |
| 44026704010385 | K964056 | 000 |
| 44026704010392 | K964056 | 000 |
| 24026704010404 | K964056 | 000 |
| 44026704010415 | K964056 | 000 |
| 44026704010422 | K964056 | 000 |
| 24026704010435 | K964056 | 000 |
| 44026704010330 | K964056 | 000 |