The following data is part of a premarket notification filed by Transidyne General Corp. with the FDA for Tracheostomy Care Kit.
| Device ID | K924243 |
| 510k Number | K924243 |
| Device Name: | TRACHEOSTOMY CARE KIT |
| Classification | Tube Tracheostomy And Tube Cuff |
| Applicant | TRANSIDYNE GENERAL CORP. 400 HERALD JOURNAL PARK Spartanburg, SC 29303 |
| Contact | Steven W Butler |
| Correspondent | Steven W Butler TRANSIDYNE GENERAL CORP. 400 HERALD JOURNAL PARK Spartanburg, SC 29303 |
| Product Code | JOH |
| CFR Regulation Number | 868.5800 [🔎] |
| Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-08-24 |
| Decision Date | 1993-06-16 |