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510(k) K201449

SimuPlus Flexible Annuloplasty Ring, SimuPlus Flexible Annuloplasty Band, SimuForm Semi-Rigid Annuloplasty Ring by Medtronic, Inc. — Product Code KRH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 1, 2020
Date Received
June 1, 2020
Clearance Type
Special
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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