510(k) K013390
K013390 is an FDA 510(k) premarket notification submitted by On Site Gas Systems, Inc. for the device "QUICKCLOT". The FDA issued a decision of Substantially Equivalent on May 23, 2002. The device falls under product code QSY (Hemostatic Wound Dressing Without Thrombin Or Other Biologics), a Class U device. On Site Gas Systems, Inc. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 23, 2002
- Date Received
- October 15, 2001
- Clearance Type
- Traditional
- Expedited Review
- Yes
- 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.