Regulatory Text
21 C.F.R. § 876.4500 — Mechanical lithotriptor.
§ 876.4500 Mechanical lithotriptor. (a) Identification. A mechanical lithotriptor is a device with steel jaws that is inserted into the urinary bladder through the urethra to grasp and crush bladder stones. (b) Classification. Class II (special controls). The device, when it is a biliary mechanical lithotripter, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9. [48 FR 53023, Nov. 23, 1983, as amended at 84 FR 71813, Dec. 30, 2019]
Source: ecfr.gov · govinfo.gov — public domain
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Root-LD v1.0 · boisestandard.org
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BS-CFR21-SEC-06E1B2
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boisestandard.org
Citation
21 C.F.R. § 876.4500
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The regulatory text of 21 C.F.R. § 876.4500 is reproduced from the official Code of Federal Regulations as published by the Office of the Federal Register and the National Archives and Records Administration.
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21 C.F.R. — public domain
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