The following data is part of a premarket notification filed by Mallinckrodt Medical with the FDA for Mallinckrodt Shiley 15mm Cap.
| Device ID | K954749 |
| 510k Number | K954749 |
| Device Name: | MALLINCKRODT SHILEY 15MM CAP |
| 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 | 1995-10-16 |
| Decision Date | 1996-01-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 70884522005359 | K954749 | 000 |