The following data is part of a premarket notification filed by Yukon Medical, Llc with the FDA for Smartsite Vented Vial Access Device.
| Device ID | K151963 |
| 510k Number | K151963 |
| Device Name: | SmartSite Vented Vial Access Device |
| Classification | Set, I.v. Fluid Transfer |
| Applicant | YUKON MEDICAL, LLC 4021 STIRRUP CREEK DRIVE SUITE200 Durham, NC 27703 |
| Contact | Carl Dupper |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | LHI |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2015-07-16 |
| Decision Date | 2015-07-31 |
| Summary: | summary |