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510(k) K183622

NasalCEASE and BleedCEASE by Les Laboratoires Brothier S.A. — Product Code QSY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 2, 2019
Date Received
December 26, 2018
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.

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