510(k) K893123
K893123 is an FDA 510(k) premarket notification submitted by Les Laboratorires Brothier, S.A. for the device "ADHESIVE BANDAGES & PADS FOR MINOR CUTS/SCRAPES". The FDA issued a decision of Substantially Equivalent on February 13, 1990. The device falls under product code QSY (Hemostatic Wound Dressing Without Thrombin Or Other Biologics), a Class U device. Les Laboratorires Brothier, S.A. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 13, 1990
- Date Received
- April 25, 1989
- 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.