510(k) K140757
K140757 is an FDA 510(k) premarket notification submitted by Z-Medica, LLC for the device "D2 HEMOSTANTIC DRESSING". The FDA issued a decision of Substantially Equivalent on July 17, 2014. The device falls under product code QSY (Hemostatic Wound Dressing Without Thrombin Or Other Biologics), a Class U device. Z-Medica, LLC has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 17, 2014
- Date Received
- March 26, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Hemostatic Wound Dressing Without Thrombin Or Other Biologics
- Device Class
- Class U
- Regulation Number
- Review Panel
- SU
- Submission Type
To temporarily control bleeding and cover external wounds.