The following data is part of a premarket notification filed by Medi-flex Hospital Products, Inc. with the FDA for Tracheostomy Care Kit.
| Device ID | K952416 |
| 510k Number | K952416 |
| Device Name: | TRACHEOSTOMY CARE KIT |
| Classification | Tube, Tracheostomy (w/wo Connector) |
| Applicant | MEDI-FLEX HOSPITAL PRODUCTS, INC. 19 BUTTERFIELD TRAIL El Paso, TX 79906 |
| Contact | Orlando Cordova |
| Correspondent | Orlando Cordova MEDI-FLEX HOSPITAL PRODUCTS, INC. 19 BUTTERFIELD TRAIL El Paso, TX 79906 |
| Product Code | BTO |
| CFR Regulation Number | 868.5800 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-05-23 |
| Decision Date | 1995-08-09 |