The following data is part of a premarket notification filed by Mallinckrodt Medical with the FDA for Percutaneous Dual Cannula Tracheostomy Tube With Low Pressure/low Profile Cuff And Disposable Inner Cannula.
| Device ID | K963732 |
| 510k Number | K963732 |
| Device Name: | PERCUTANEOUS DUAL CANNULA TRACHEOSTOMY TUBE WITH LOW PRESSURE/LOW PROFILE CUFF AND DISPOSABLE INNER CANNULA |
| 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 | 1996-09-17 |
| Decision Date | 1997-06-26 |
| Summary: | summary |