The following data is part of a premarket notification filed by Avenir Performance Europeenne Medical (apem) with the FDA for Vial Adapter Ø20 Mm , Vial Adapter Ø13 Mm.
| Device ID | K190816 |
| 510k Number | K190816 |
| Device Name: | Vial Adapter Ø20 Mm , Vial Adapter Ø13 Mm |
| Classification | Set, I.v. Fluid Transfer |
| Applicant | Avenir Performance Europeenne Medical (APEM) ZI Route De Souppes Château-landon, FR 77570 |
| Contact | Fatoumata Dao |
| Correspondent | Om V. Singh Technology Sciences Group, Inc. 1150 18th Street, NW, Suite 1000 Washington, DC 20036 |
| Product Code | LHI |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-03-29 |
| Decision Date | 2019-11-19 |
| Summary: | summary |