510(k) K183208
K183208 is an FDA 510(k) premarket notification submitted by Speciality Fibres and Materials, Ltd. for the device "Suprasorb A + Ag R". The FDA issued a decision of Substantially Equivalent on August 15, 2019. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Speciality Fibres and Materials, Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 15, 2019
- Date Received
- November 19, 2018
- 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