510(k) K160872
K160872 is an FDA 510(k) premarket notification submitted by Global Health Solutions, LLC for the device "PolyPlex Wound Dressing". The FDA issued a decision of Substantially Equivalent on Nov 23, 2016. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Global Health Solutions, LLC has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 23, 2016
- Date Received
- Mar 30, 2016
- 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)