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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device catheter, peritoneal, long-term indwelling, exempt
Regulation Description Peritoneal dialysis system and accessories.
Definition This product code is the class II exempt counterpart of FJS, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 876.9 and the specific limitations of exemption as stated in the “Physical State” field of this product code description.
Product CodePTU
Regulation Number 876.5630
Device Class 2

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