The following data is part of a premarket notification filed by Medimop Medical Project Ltd. with the FDA for Vial Adapter 15mm.
Device ID | K171796 |
510k Number | K171796 |
Device Name: | Vial Adapter 15mm |
Classification | Set, I.v. Fluid Transfer |
Applicant | Medimop Medical Project Ltd. 17 Hatidhar St Ra'anana, IL 43665 |
Contact | Jeffrey Ravel |
Correspondent | Jeffrey Ravel Medimop Medical Project Ltd. 17 Hatidhar St Ra'anana, IL 43665 |
Product Code | LHI |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-06-16 |
Decision Date | 2017-10-12 |
Summary: | summary |