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U.S. Department of Health and Human Services

Product Classification

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Device stripper, vein, external
Regulation Description External vein stripper.
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeDWQ
Premarket Review Cardiovascular Devices (OHT2)
Circulatory Support, Structural and Vascular Devices (DHT2B)
Submission Type 510(k)
Regulation Number 870.4885
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons
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