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Code of Federal Regulations (Last Updated: April 5, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter H - Medical Devices |
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Part 876 - Gastroenterology-Urology Devices |
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Subpart E - Surgical Devices |
§ 876.4650 - Water jet renal stone dislodger system.
Latest version.
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§ 876.4650 Water jet renal stone dislodger system.
(a) Identification. A water jet renal stone dislodger system is a device used to dislodge stones from renal calyces (recesses of the pelvis of the kidney) by means of a pressurized stream of water through a conduit. The device is used in the surgical removal of kidney stones.
(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.
[48 FR 53023, Nov. 23, 1983, as amended at 63 FR 59228, Nov. 3, 1998]