The following data is part of a premarket notification filed by Smiths Industries Medical Systems, Inc. with the FDA for Percutaneous Tracheostomy Kit.
| Device ID | K936133 |
| 510k Number | K936133 |
| Device Name: | PERCUTANEOUS TRACHEOSTOMY KIT |
| Classification | Tube Tracheostomy And Tube Cuff |
| Applicant | SMITHS INDUSTRIES MEDICAL SYSTEMS, INC. 15 KIT ST. Keene, NH 03431 |
| Contact | Timothy J Talcott |
| Correspondent | Timothy J Talcott SMITHS INDUSTRIES MEDICAL SYSTEMS, INC. 15 KIT ST. Keene, NH 03431 |
| 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 | 1993-12-23 |
| Decision Date | 1994-03-23 |