The following data is part of a premarket notification filed by American Healthcare Corp. with the FDA for Tracheostomy Care Set With Gloves.
| Device ID | K923834 |
| 510k Number | K923834 |
| Device Name: | TRACHEOSTOMY CARE SET WITH GLOVES |
| Classification | Tube, Tracheostomy (w/wo Connector) |
| Applicant | AMERICAN HEALTHCARE CORP. ONE AMERICAN HEALTHCARE PLAZA 3611 KENNEDY ROAD South Plainfield, NJ 07080 |
| Contact | Ralph S Jarrett |
| Correspondent | Ralph S Jarrett AMERICAN HEALTHCARE CORP. ONE AMERICAN HEALTHCARE PLAZA 3611 KENNEDY ROAD South Plainfield, NJ 07080 |
| Product Code | BTO |
| CFR Regulation Number | 868.5800 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-31 |
| Decision Date | 1992-12-10 |