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U.S. Department of Health and Human Services

Product Classification

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Device microsphere, trace
Regulation Description Trace microsphere.
Definition Call for pmas 12/26/96 (61 fr 50706 (9/27/96)).
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeDQG
Premarket Review Office of Device Evaluation (ODE)
Division of Cardiovascular Devices (DCD)
Cardiac Diagnostics Devices Branch (CDDB)
Submission Type PMA
Regulation Number 870.1360
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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