The following data is part of a premarket notification filed by Mallinckrodt Medical with the FDA for Shiley Cuffed Pediatric Tracheostomy Tube; Long Cuffed.
| Device ID | K955680 |
| 510k Number | K955680 |
| Device Name: | SHILEY CUFFED PEDIATRIC TRACHEOSTOMY TUBE; LONG CUFFED |
| Classification | Tube Tracheostomy And Tube Cuff |
| Applicant | MALLINCKRODT MEDICAL 675 MCDONNELL BLVD. P.O. BOX 5840 St. Louis, MO 63134 |
| Contact | Michael B Schoeck |
| Correspondent | Michael B Schoeck MALLINCKRODT MEDICAL 675 MCDONNELL BLVD. P.O. BOX 5840 St. Louis, MO 63134 |
| Product Code | JOH |
| CFR Regulation Number | 868.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-12-14 |
| Decision Date | 1996-03-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884522029131 | K955680 | 000 |
| 10884521554665 | K955680 | 000 |
| 30884521109319 | K955680 | 000 |
| 90884521554784 | K955680 | 000 |
| 90884521554777 | K955680 | 000 |
| 10884521554641 | K955680 | 000 |
| 10884521554634 | K955680 | 000 |
| 30884521109562 | K955680 | 000 |
| 30884521109555 | K955680 | 000 |
| 30884521109296 | K955680 | 000 |
| 30884521109289 | K955680 | 000 |
| 30884521109579 | K955680 | 000 |
| 90884521554753 | K955680 | 000 |
| 10884522029124 | K955680 | 000 |
| 10884522029117 | K955680 | 000 |
| 10884522029100 | K955680 | 000 |
| 10884522029063 | K955680 | 000 |
| 10884522029056 | K955680 | 000 |
| 10884522029049 | K955680 | 000 |
| 10884522029032 | K955680 | 000 |
| 30884521109302 | K955680 | 000 |
| 30884521109548 | K955680 | 000 |
| 90884521554760 | K955680 | 000 |
| 10884521554658 | K955680 | 000 |