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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Staple, Implantable
510(k) Number K181668
Device Name FasTouch Absorbable Fixation System
Applicant
Via Surgical , Ltd.
Mitzpe Kineret St. 22/1
Amirim,  IL 2011500
Applicant Contact Ofek Levin
Correspondent
Northstar Biomedical Associates
93 Benefit St.
Providence,  RI  02904
Correspondent Contact Leo Basta
Regulation Number878.4750
Classification Product Code
GDW  
Date Received06/25/2018
Decision Date 03/13/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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