The following data is part of a premarket notification filed by Medimix Products, Inc. with the FDA for Double-ject Transfer Needle.
| Device ID | K860113 |
| 510k Number | K860113 |
| Device Name: | DOUBLE-JECT TRANSFER NEEDLE |
| Classification | Set, I.v. Fluid Transfer |
| Applicant | MEDIMIX PRODUCTS, INC. 3578 TWIN OAKS DR. Napa, CA 94558 |
| Contact | Wilton Lee |
| Correspondent | Wilton Lee MEDIMIX PRODUCTS, INC. 3578 TWIN OAKS DR. Napa, CA 94558 |
| Product Code | LHI |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-01-13 |
| Decision Date | 1986-02-12 |