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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device panendoscope (gastroduodenoscope)
Regulation Description Endoscope and accessories.
Definition If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Product CodeFAK
Regulation Number 876.1500
Device Class 2


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