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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hemostatic Wound Dressing Without Thrombin Or Other Biologics
510(k) Number K080648
Device Name TRAUMASTAT RAPID HEMOSTATIC WOUND DRESSING BANDAGE
Applicant
Ore-Medix, LLC
7651 S 700 W.
Suite 105
Midvale,  UT  84047
Applicant Contact DONALD F GRABARZ
Correspondent
Ore-Medix, LLC
7651 S 700 W.
Suite 105
Midvale,  UT  84047
Correspondent Contact DONALD F GRABARZ
Classification Product Code
QSY  
Date Received03/07/2008
Decision Date 05/07/2008
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Expedited Review Yes
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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