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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ring, Annuloplasty
510(k) Number K103812
Device Name MITRA-LIFT
Applicant
Sciencity Co., Ltd.
325 N. Puente St., Unit B
Brea,  CA  92821
Applicant Contact JOYCE BANG
Correspondent
Sciencity Co., Ltd.
325 N. Puente St., Unit B
Brea,  CA  92821
Correspondent Contact JOYCE BANG
Regulation Number870.3800
Classification Product Code
KRH  
Date Received12/29/2010
Decision Date 05/18/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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