The following data is part of a premarket notification filed by Mada Medical Products, Inc. with the FDA for Medajet Xl - Jet Injector.
| Device ID | K850754 |
| 510k Number | K850754 |
| Device Name: | MEDAJET XL - JET INJECTOR |
| Classification | Injector, Fluid, Non-electrically Powered |
| Applicant | MADA MEDICAL PRODUCTS, INC. 60 COMMERCE RD. Carlstadt, NJ 07072 |
| Contact | Adam |
| Correspondent | Adam MADA MEDICAL PRODUCTS, INC. 60 COMMERCE RD. Carlstadt, NJ 07072 |
| Product Code | KZE |
| CFR Regulation Number | 880.5430 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-02-25 |
| Decision Date | 1985-12-10 |