510(k) K061767
K061767 is an FDA 510(k) premarket notification submitted by Z-Medica Corporation for the device "QUIKCLOT 1ST RESPONSE & QUIKCLOT ACS+". The FDA issued a decision of Substantially Equivalent on July 19, 2006. The device falls under product code QSY (Hemostatic Wound Dressing Without Thrombin Or Other Biologics), a Class U device. Z-Medica Corporation has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 19, 2006
- Date Received
- June 23, 2006
- Clearance Type
- Special
- 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.