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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 K140313
Device Name STOPSBLEEDING TOPICAL HEMOSTAT POWDER AND FOAM
Applicant
COAG MEDICAL LLC
4486 TIMBERLINE CT.
VADNAIS HEIGHTS,  MN  55127
Applicant Contact BERNARD HORWATH
Correspondent
COAG MEDICAL LLC
4486 TIMBERLINE CT.
VADNAIS HEIGHTS,  MN  55127
Correspondent Contact BERNARD HORWATH
Classification Product Code
QSY  
Subsequent Product Code
LYA  
Date Received02/10/2014
Decision Date 07/28/2014
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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