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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name dressing, wound, drug
510(K) Number K122886
Device Name NEXSTAT PLUS AND NEXFOAM PLUS TOPICAL HEMOSTAT DRESSING
Applicant
HEMOSTASIS, LLC
4486 timberline ct
vadnais hts,  MN  55127
Contact bernard horwath
Classification Product Code
FRO  
Date Received09/20/2012
Decision Date 11/15/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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