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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 K172155
Device Name StatGuard Hemostatic Patch, StatGuard Hemostatic Dressing
Applicant
Statguard, LLC
7555 Cason Lane
Gladstone,  OR  97027
Applicant Contact Gary Mills
Correspondent
Statguard, LLC
7555 Cason Lane
Gladstone,  OR  97027
Correspondent Contact Gary Mills
Classification Product Code
QSY  
Date Received07/17/2017
Decision Date 04/12/2018
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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