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510(k) K103812

MITRA-LIFT by Sciencity Co., Ltd. — Product Code KRH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 18, 2011
Date Received
December 29, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ring, Annuloplasty
Device Class
Class II
Regulation Number
870.3800
Review Panel
CV
Submission Type

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