510(k) K120958
K120958 is an FDA 510(k) premarket notification submitted by Hemostasis, LLC for the device "POSISEP AND POSISEP X HEMOSTAT DRESSINGS". The FDA issued a decision of Substantially Equivalent on July 25, 2012. The device falls under product code QSY (Hemostatic Wound Dressing Without Thrombin Or Other Biologics), a Class U device. Hemostasis, LLC has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 25, 2012
- Date Received
- March 30, 2012
- 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.