510(k) K113560
K113560 is an FDA 510(k) premarket notification submitted by Medtrade Products , Ltd. for the device "CELOX GAUZE PRO". The FDA issued a decision of Substantially Equivalent on August 1, 2012. The device falls under product code QSY (Hemostatic Wound Dressing Without Thrombin Or Other Biologics), a Class U device. Medtrade Products , Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 1, 2012
- Date Received
- December 1, 2011
- 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.