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U.S. Department of Health and Human Services

Product Classification

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Device device,anastomotic,microvascular
Regulation Description Implantable clip.
Regulation Medical Specialty General & Plastic Surgery
Review Panel Cardiovascular
Product CodeMVR
Premarket Review Office of Device Evaluation (ODE)
Division of Cardiovascular Devices (DCD)
Cardiac Diagnostics Devices Branch (CDDB)
Submission Type 510(k)
Regulation Number 878.4300
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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