The following data is part of a premarket notification filed by Medimop Medical Projects, Ltd. with the FDA for Vial Connector 13mm Closed Collar.
Device ID | K132040 |
510k Number | K132040 |
Device Name: | VIAL CONNECTOR 13MM CLOSED COLLAR |
Classification | Set, I.v. Fluid Transfer |
Applicant | MEDIMOP MEDICAL PROJECTS, LTD. 17 HATIDHAR ST. Ra'anana, IL 4366519 |
Contact | Ilanit Goldgraber |
Correspondent | Ilanit Goldgraber MEDIMOP MEDICAL PROJECTS, LTD. 17 HATIDHAR ST. Ra'anana, IL 4366519 |
Product Code | LHI |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-07-02 |
Decision Date | 2013-07-31 |
Summary: | summary |