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510(k) K150963

AnsCare ChitoClot Pad by Benq Materials Corporation — Product Code QSY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 5, 2015
Date Received
April 10, 2015
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.

Other clearances by Benq Materials Corporation

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  • K143462 — AnsCare ChitoClot Gauze (prescription use), AnsCare ChitoClot Gauze (over-the-co (May 8, 2015)

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  • K240454 — RESPONDER® Polysaccharide Hemostat (March 15, 2024)
  • K220525 — RESPONDER Polysaccharide Hemostat (December 4, 2023)
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