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Electronic Code of Federal Regulations

e-CFR data is current as of November 14, 2019

Title 21Chapter ISubchapter HPart 876Subpart F → §876.5160


Title 21: Food and Drugs
PART 876—GASTROENTEROLOGY-UROLOGY DEVICES
Subpart F—Therapeutic Devices


§876.5160   Urological clamp for males.

(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 or use on females, 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, 1963, as amended at 65 FR 2317, Jan. 14, 2000]

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