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U.S. Department of Health and Human Services

Product Classification

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Device stripper, vein, external, reprocessed
Regulation Description External vein stripper.
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeNLJ
Premarket Review Office of Device Evaluation (ODE)
Division of Cardiovascular Devices (DCD)
Cardiac Diagnostics Devices Branch (CDDB)
Submission Type 510(k)
Regulation Number 870.4885
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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