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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 K140573
Device Name WOUNDCLOT HEMOSTATIC GAUZE
Applicant
Core Scientific , Ltd.
Pob 3
Shave-Zion,  IL 22806
Applicant Contact Sigalit Ariely-Portnoy
Correspondent
Core Scientific , Ltd.
Pob 3
Shave-Zion,  IL 22806
Correspondent Contact Sigalit Ariely-Portnoy
Classification Product Code
QSY  
Date Received03/06/2014
Decision Date 11/24/2014
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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