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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
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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