The following data is part of a premarket notification filed by Rusch Intl. with the FDA for The Percuquick Set For Percutaneous Dilation Tracheostomy.
| Device ID | K011210 |
| 510k Number | K011210 |
| Device Name: | THE PERCUQUICK SET FOR PERCUTANEOUS DILATION TRACHEOSTOMY |
| Classification | Tube Tracheostomy And Tube Cuff |
| Applicant | RUSCH INTL. 50 PLANTATION DR. Jaffery, NH 03452 |
| Contact | Julie A Beaumont |
| Correspondent | Julie A Beaumont RUSCH INTL. 50 PLANTATION DR. Jaffery, 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 | 2001-04-19 |
| Decision Date | 2001-08-15 |