The following data is part of a premarket notification filed by Mallinckrodt Medical Tpi, Inc. with the FDA for Reusable Cannula Tracheostomy Tubes, Modified Heads.
| Device ID | K936224 |
| 510k Number | K936224 |
| Device Name: | REUSABLE CANNULA TRACHEOSTOMY TUBES, MODIFIED HEADS |
| Classification | Tube Tracheostomy And Tube Cuff |
| Applicant | MALLINCKRODT MEDICAL TPI, INC. 1595 DEERE AVE. P.O. BOX 19614 Irvine, CA 92714 |
| Contact | Amy Boucly |
| Correspondent | Amy Boucly MALLINCKRODT MEDICAL TPI, INC. 1595 DEERE AVE. P.O. BOX 19614 Irvine, CA 92714 |
| Product Code | JOH |
| CFR Regulation Number | 868.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-12-07 |
| Decision Date | 1994-08-30 |