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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device system, balloon, intra-aortic and control, reprocessed
Regulation Description Intra-aortic balloon and control system.
Definition Reprocessed Single Use Device (SUD) requiring 510(k) and previously exempt from submission of validation data. As of 9/29/05 FR notice validation data is now required. http://www.fda.gov/cdrh/reprocessing/fr-list2.html
Product CodeNKO
Regulation Number 870.3535
Device Class 3

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