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U.S. Department of Health and Human Services

Product Classification
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Device catheter, intravascular occluding
Regulation Description Intravascular occluding catheter.
Definition Call for pmas to be filed by 12/26/96 (61 fr 50708 (9/27/96)).
Regulation Medical Specialty Neurology
Review Panel Neurology
Product CodeHBZ
Submission Type PMA
Regulation Number 882.5150
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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