The following data is part of a premarket notification filed by American Healthcare Corp. with the FDA for Tracheostomy Care Set W/forceps & Gauze Trach Dres.
| Device ID | K924195 |
| 510k Number | K924195 |
| Device Name: | TRACHEOSTOMY CARE SET W/FORCEPS & GAUZE TRACH DRES |
| 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 (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-08-20 |
| Decision Date | 1993-01-06 |