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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device transilluminator (diaphanoscope)
Regulation Description Transilluminator for breast evaluation.
Definition Classified August 17, 1995: 60 fr 36639: Classification into Class III for the transilluminator (diaphanoscope or lightscanner) for breast evaluation requires manufacturers of transilluminators to submit safety and effectiveness tests for the device.
Product CodeLEK
Regulation Number 892.1990
Device Class 2

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