21 CFR 882.4600 - Leukotome.

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There are 2 Updates appearing in the Federal Register for 21 CFR 882. View below or at eCFR (GPOAccess)
§ 882.4600 Leukotome.
(a) Identification. A leukotome is a device used to cut sections out of the brain.
(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9.
[44 FR 51730, Sept. 4, 1979, as amended at 59 FR 63012, Dec. 7, 1994; 66 FR 38808, July 25, 2001]

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.

  • 2014-07-08; vol. 79 # 130 - Tuesday, July 8, 2014
    1. 79 FR 38457 - Medical Devices; Neurological Devices; Classification of the Transcranial Magnetic Stimulator for Headache
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final order.
      This order is effective August 7, 2014. The classification was applicable on December 13, 2013.
      21 CFR Part 882

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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 882 after this date.

  • 2014-07-08; vol. 79 # 130 - Tuesday, July 8, 2014
    1. 79 FR 38457 - Medical Devices; Neurological Devices; Classification of the Transcranial Magnetic Stimulator for Headache
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final order.
      This order is effective August 7, 2014. The classification was applicable on December 13, 2013.
      21 CFR Part 882