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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device gastroenterology-urology accessories to a biopsy instrument
Regulation Description Gastroenterology-urology accessories to a biopsy instrument.
Definition A gastroenterology-urology accessory to a biopsy instrument is an accessory used to remove a specimen of tissue for microscopic examination by cutting or aspiration. This generic type of device includes a syringe for specimen aspiration and a biopsy channel adaptor. This device does not include accessories to biopsy instruments used in other medical specialty areas.
Product CodeQFZ
Regulation Number 876.1080
Device Class 1

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