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510(k) Data Aggregation
K Number
K081183Device Name
WOUNDSTAT
Manufacturer
TRAUMACURE INC.
Date Cleared
2008-06-19
(55 days)
Product Code
QSY, FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
TRAUMACURE INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
WoundStat™ wound dressing for OTC is indicated for temporary external use to control bleeding from minor cuts and abrasions of the skin.
Device Description
WoundStat™ is a clay-based, granufar hemostatic agent that is poured on a moderate to severe wound and held in place until it adheres to the wound and hemostasis is achieved. The device is packaged in a foil package and is provided sterile.
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K Number
K071936Device Name
WOUNDSTAT, MODEL TC1001
Manufacturer
TRAUMACURE INC.
Date Cleared
2007-08-23
(41 days)
Product Code
QSY, FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
TRAUMACURE INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
WoundStat™ is intended for emergency use only as an external temporary traumatic wound treatment to achieve hemostasis for moderate to severe bleeding.
Device Description
WoundStat™ is a clay-based, granular hemostatic agent that is poured on or into a moderate to severe wound and held in place until it adheres to the wound and hemostasis is achieved. The device is packaged in a foil package and is provided sterile.
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