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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 K160679
Device Name WoundClot9
Applicant
Core Scientific Creation , Ltd.
Yohanan Hasandlar 4 St.
Pob 2270, 4464102 Israel
Kfar Saba,  IL 4464102
Applicant Contact YUVAL YASKIL
Correspondent
Gsap , Ltd.
Pob 3, Shave-Zion,  IL 22806
Correspondent Contact Sigalit Ariely-Portnoy
Classification Product Code
QSY  
Date Received03/10/2016
Decision Date 08/08/2016
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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