The following data is part of a premarket notification filed by Medimop Medical Projects, Ltd. with the FDA for Swabable Vial Adapter 13mm, Swabable Vial Adapter 20mm.
| Device ID | K072511 |
| 510k Number | K072511 |
| Device Name: | SWABABLE VIAL ADAPTER 13MM, SWABABLE VIAL ADAPTER 20MM |
| 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 | 2007-09-06 |
| Decision Date | 2007-12-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 27290108240980 | K072511 | 000 |
| 27290108240911 | K072511 | 000 |
| 27290108240744 | K072511 | 000 |
| 27290108240607 | K072511 | 000 |
| 27290108240492 | K072511 | 000 |
| 27290108240355 | K072511 | 000 |
| 27290108240287 | K072511 | 000 |
| 27290108240102 | K072511 | 000 |
| 27290108240027 | K072511 | 000 |