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 |