The following data is part of a premarket notification filed by Medimop Medical Projects, Ltd. with the FDA for Vial2bag.
Device ID | K072759 |
510k Number | K072759 |
Device Name: | VIAL2BAG |
Classification | Set, I.v. Fluid Transfer |
Applicant | MEDIMOP MEDICAL PROJECTS, LTD. 101 GORDON DRIVE Lionville, PA 19341 |
Contact | Ari Y Sobel |
Correspondent | Ari Y Sobel MEDIMOP MEDICAL PROJECTS, LTD. 101 GORDON DRIVE Lionville, PA 19341 |
Product Code | LHI |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-09-28 |
Decision Date | 2007-12-13 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
27290108240041 | K072759 | 000 |
27290108240034 | K072759 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
VIAL2BAG 78639813 3584651 Live/Registered |
WEST PHARMA. SERVICES IL, LTD. 2005-05-31 |