[Federal Register Volume 65, Number 150 (Thursday, August 3, 2000)]
[Rules and Regulations]
[Pages 47669-47670]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-19593]


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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.

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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:


Sec. 868.5115  [Corrected]

    On page 39099, in the third column, in Sec. 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

[[Page 47670]]

from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to Sec. 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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