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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Suture, Nonabsorbable, Synthetic, Polyethylene
510(k) Number K142241
Device Name LARIAT sulture Delivery Device
Applicant
Sentreheart, Inc.
300 Saginaw Dr.
Redwood City,  CA  94063 -0000
Applicant Contact Kit Cariquitan
Correspondent
Sentreheart, Inc.
300 Saginaw Dr.
Redwood City,  CA  94063 -0000
Correspondent Contact Kit Cariquitan
Regulation Number878.5000
Classification Product Code
GAT  
Subsequent Product Code
HCF  
Date Received08/13/2014
Decision Date 09/12/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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