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510(k) K230318

Memo 3D Semirigid Annuloplasty Ring; Memo 3D ReChord Semirigid Annuloplasty Ring; Memo 4D Semirigid Annuloplasty Ring by Corcym S.r.l. — Product Code KRH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 7, 2023
Date Received
February 6, 2023
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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