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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mesh, Surgical
510(k) Number K162388
Device Name CuraSeal Percutaneous Intraluminal Closure System for Anorectal Fistulas(PICS-AF)
Applicant
CURASEAL, INC.
2231 CALLE DE LUNA
SANTA CLARA,  CA  95054
Applicant Contact HAROLD F. CARRISON
Correspondent
EXPERIEN GROUP, LLC
755 N MATHILDA AVENUE
SUNNYVALE,  CA  94085
Correspondent Contact KIT CARIQUITAN
Regulation Number878.3300
Classification Product Code
FTM  
Subsequent Product Code
FTL  
Date Received08/25/2016
Decision Date 02/03/2017
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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