Medical Devices; Anesthesiology Devices; Classification of Devices to Relieve Upper Airway Obstruction; Correction
fda-device · Food and Drug Administration · Rule · Published 2000-08-03 · Effective 2000-08-03 · 65 FR 47669
Document
Document number
00-19593
Federal Register citation
65 FR 47669
CFR reference
21 CFR 868
Type
Rule
Action
Final rule; correction.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2000-08-03
Effective date
2000-08-03
HHS docket
Docket No. 00P-1117
Abstract
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.