510(k) K160379
K160379 is an FDA 510(k) premarket notification submitted by Molnlycke Health Care Us, LLC for the device "Exufiber Ag+". The FDA issued a decision of Substantially Equivalent on August 25, 2016. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Molnlycke Health Care Us, LLC has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 25, 2016
- Date Received
- February 10, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dressing, Wound, Drug
- Device Class
- Class U
- Regulation Number
- Review Panel
- SU
- Submission Type