510(k) K100591
K100591 is an FDA 510(k) premarket notification submitted by Abigo Medical AB for the device "SORBACT". The FDA issued a decision of Substantially Equivalent on January 24, 2011. 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
- January 24, 2011
- Date Received
- March 2, 2010
- 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