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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 K132698
Device Name FASTOUCH FIXATION SYSTEM
Applicant
VIA SURGICAL LTD.
93 BENEFIT ST.
PROVIDENCE,  RI  02904
Applicant Contact LEO BASTA
Correspondent
VIA SURGICAL LTD.
93 BENEFIT ST.
PROVIDENCE,  RI  02904
Correspondent Contact LEO BASTA
Regulation Number878.4750
Classification Product Code
GDW  
Date Received08/29/2013
Decision Date 03/14/2014
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
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