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U.S. Department of Health and Human Services

Product Classification

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Device ring, annuloplasty
Regulation Description Annuloplasty ring.
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeKRH
Premarket Review Office of Device Evaluation (ODE)
Division of Cardiovascular Devices (DCD)
Structural Heart Devices Branch (SHDB)
Submission Type 510(k)
Regulation Number 870.3800
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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