510(k) K173844
K173844 is an FDA 510(k) premarket notification submitted by Specialty Fibres And Materials, Ltd. for the device "Titan Ag 200". The FDA issued a decision of Substantially Equivalent on Aug 9, 2018. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Specialty Fibres And Materials, Ltd. has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 9, 2018
- Date Received
- Dec 19, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dressing, Wound, Drug
- Device Class
- Class U
- Review Panel
- SU
- Submission Type
- 510(k)