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U.S. Department of Health and Human Services

Product Classification

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Device device, biopsy, endomyocardial
Regulation Description Endomyocardial biopsy device.
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeDWZ
Premarket Review Cardiovascular Devices (OHT2)
Circulatory Support, Structural and Vascular Prostheses (DHT2B)
Submission Type 510(k)
Regulation Number 870.4075
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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