Regulatory Text
21 C.F.R. § 876.5160 — Urological clamp.
§ 876.5160 Urological clamp. (a) Identification. A urological clamp for males is a device used to close the urethra of a male to control urinary incontinence or to hold anesthetic or radiography contrast media in the urethra temporarily. It is an external clamp. (b) Classification. Class I (general controls). Except when intended for internal use, the device 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, 1963, as amended at 65 FR 2317, Jan. 14, 2000; 84 FR 71814, Dec. 30, 2019]
Source: ecfr.gov · govinfo.gov — public domain
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Root-LD Entity Data
◈ Machine-Readable Provenance Record
Root-LD v1.0 · boisestandard.org
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BS-CFR21-SEC-19D1EC
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REGULATION / FEDERAL-CFR-SECTION
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boisestandard.org
Citation
21 C.F.R. § 876.5160
Corpus
CFR — Code of Federal Regulations
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PRIMARY-SOURCE
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20c9860e66ff041e...
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The regulatory text of 21 C.F.R. § 876.5160 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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Title 21 — Food and Drugs
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21 C.F.R. — public domain
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