The following data is part of a premarket notification filed by American Healthcare Corp. with the FDA for I.v. Start Kit (ahc-50-54954.
| Device ID | K924192 |
| 510k Number | K924192 |
| Device Name: | I.V. START KIT (AHC-50-54954 |
| Classification | Tape And Bandage, Adhesive |
| 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 | KGX |
| CFR Regulation Number | 880.5240 [🔎] |
| Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-08-20 |
| Decision Date | 1993-08-27 |