21 CFR 876.5830 - Hemodialyzer with disposable insert (Kiil type).

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There are 6 Updates appearing in the Federal Register for 21 CFR Part 876. View below or at eCFR (GPOAccess)
§ 876.5830 Hemodialyzer with disposable insert (Kiil type).
(a) Identification. A hemodialyzer with disposable inserts (Kiil type) is a device that is used as a part of an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and that includes disposable inserts consisting of layers of semipermeable membranes which are sandwiched between support plates. The device is used with the extracorporeal blood system and the dialysate delivery system of the hemodialysis system and accessories (§ 876.5820).
(b) Classification. Class II (performance standards).
[48 FR 53023, Nov. 23, 1983, as amended at 53 FR 11253, Apr. 6, 1988]

Title 21 published on 2014-04-01.

The following are only the Rules published in the Federal Register after the published date of Title 21.

For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.

  • 2015-05-28; vol. 80 # 102 - Thursday, May 28, 2015
    1. 80 FR 30353 - Medical Devices; Gastroenterology-Urology Devices; Classification of the Vibrator for Climax Control of Premature Ejaculation
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final order.
      This order is effective May 28, 2015. The classification was applicable on March 20, 2015.
      21 CFR Part 876

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United States Code

Title 21 published on 2014-04-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 876 after this date.

  • 2015-05-28; vol. 80 # 102 - Thursday, May 28, 2015
    1. 80 FR 30353 - Medical Devices; Gastroenterology-Urology Devices; Classification of the Vibrator for Climax Control of Premature Ejaculation
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final order.
      This order is effective May 28, 2015. The classification was applicable on March 20, 2015.
      21 CFR Part 876