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U.S. Department of Health and Human Services

Product Classification

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Device rotator, prosthetic heart valve
Regulation Description Prosthetic heart valve holder.
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeMOP
Premarket Review Office of Device Evaluation (ODE)
Division of Cardiovascular Devices (DCD)
Structural Heart Devices Branch (SHDB)
Submission Type 510(k)
Regulation Number 870.3935
Device Class 1
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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