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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device scalp cooling system
Regulation Description Scalp cooling system to reduce the likelihood of chemotherapy-induced alopecia.
Definition A scalp cooling system is intended to reduce or prevent the frequency and severity of alopecia during chemotherapy in which alopecia-inducing chemotherapeutic agents are used.
Product CodePMC
Regulation Number 878.4360
Device Class 2

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