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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 K070211
Device Name TRAUMARREST AND BLEEDARREST HEMOSTATIC PARTICLES AND FOAM
Applicant
Hemostasis, LLC
5000 Township Pkwy.
St. Paul,  MN  55110
Applicant Contact KEITH ROBERTS
Correspondent
Hemostasis, LLC
5000 Township Pkwy.
St. Paul,  MN  55110
Correspondent Contact KEITH ROBERTS
Classification Product Code
QSY  
Subsequent Product Code
LYA  
Date Received01/22/2007
Decision Date 04/05/2007
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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