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U.S. Department of Health and Human Services

Product Classification

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Device trocar, reprocessed
Regulation Description Trocar.
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeNMK
Premarket Review Office of Device Evaluation (ODE)
Division of Cardiovascular Devices (DCD)
Circulatory Support Devices Branch (CSDB)
Submission Type 510(k)
Regulation Number 870.1390
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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