510(k) K141019
K141019 is an FDA 510(k) premarket notification submitted by Fenwal, Inc. for the device "AMICUS SEPARATOR SYSTEM/ AMICUS SEPERATOR SYSTEM;REFURBISHED". The FDA issued a decision of Substantially Equivalent on June 10, 2014. The device falls under product code LKN (Separator, Automated, Blood Cell And Plasma, Therapeutic), a Class U device. Fenwal, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 10, 2014
- Date Received
- April 21, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Separator, Automated, Blood Cell And Plasma, Therapeutic
- Device Class
- Class U
- Regulation Number
- Review Panel
- GU
- Submission Type