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U.S. Department of Health and Human Services

Product Classification

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Device marker, ostia, aorto-saphenous vein
Regulation Medical Specialty General & Plastic Surgery
Review Panel Cardiovascular
Product CodeKPK
Premarket Review Office of Device Evaluation (ODE)
Division of Cardiovascular Devices (DCD)
Circulatory Support Devices Branch (CSDB)
Submission Type 510(k)
Regulation Number 878.4650
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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