Rules and Regulations. Final rule; correction

254 words·~1 min read·/register/2000/08/03/00-19593

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BILLING CODE 4160-01-F DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 868 [Docket No. 00P-1117] Medical Devices; Anesthesiology Devices; Classification of Devices to Relieve Upper Airway Obstruction; Correction AGENCY: Food and Drug Administration, HHS. ACTION: Final rule; correction. SUMMARY: The Food and Drug Administration

(FDA)is correcting a final rule that appeared in the **Federal Register** of June 23, 2000 (65 FR 39098). The document classified devices to relieve acute upper airway obstruction. These type devices were classified into class II. The preamble to the final rule correctly states that the devices were exempt from premarket notification, but this exemption was not reflected in the regulatory text. This document corrects that error. DATES: This rule is effective August 3, 2000. FOR FURTHER INFORMATION CONTACT: Carroll O'Neill, Center for Devices and Radiological Health (HFZ-450), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-443-8262, ext. 170. SUPPLEMENTARY INFORMATION: In FR Doc. 00-15864, appearing on page 39098 in the **Federal Register** of June 23, 2000, the following correction is made: § 868.5115 [Corrected] On page 39099, in the third column, in § 868.5115 *Device to relieve acute upper airway obstruction* , in paragraph (b), insert at the end of the paragraph the sentence “The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to § 868.9.” Dated: July 17, 2000. Linda S. Kahan, Deputy Director for Regulations Policy, Center for Devices and Radiological Health. [FR Doc. 00-19593 Filed 8-2-00; 8:45 am]

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