510(k) K133121
K133121 is an FDA 510(k) premarket notification submitted by Sam Medical Products for the device "CHITO-SAM 100,4IN X4IN,CHITO-SAM, 3IN X6FT, CHITO-SAM 100,3IN X10FT, CHITO-SAM ACTIVE, 4INX4IN,CHITO-SAM ACTIVE, 3INX6FT". The FDA issued a decision of Substantially Equivalent on May 22, 2014. The device falls under product code QSY (Hemostatic Wound Dressing Without Thrombin Or Other Biologics), a Class U device. Sam Medical Products has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 22, 2014
- Date Received
- September 30, 2013
- 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.