510(k) K171225
K171225 is an FDA 510(k) premarket notification submitted by Abigo Medical AB for the device "Sorbact Wound Dressing-Ribbon Gauze". The FDA issued a decision of Substantially Equivalent on August 21, 2017. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Abigo Medical AB has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 21, 2017
- Date Received
- April 26, 2017
- 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