[Federal Register Volume 60, Number 170 (Friday, September 1, 1995)]
[Proposed Rules]
[Pages 45684-45685]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-21737]



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[[Page 45685]]


DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 862, 866, 868, 870, 872, 874, 876, 878, 880, 882, 884, 
886, 888, 890, and 892

[Docket No. 95N-0139]


Medical Devices; Proposed Reclassification and Exemption From 
Premarket Notification for Certain Classified Devices; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; correction.

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SUMMARY: The Food and Drug Administration (FDA) is correcting a 
proposed rule that appeared in the Federal Register of July 28, 1995 
(60 FR 38902). The document proposed to reclassify 112 generic types of 
class II devices into class I based on new information respecting the 
devices, and exempt the 112 generic types of devices, along with 12 
already classified generic types of class I devices, from the 
requirement of premarket notification, with limitations. The document 
was published with some errors. This document corrects those errors.

DATES: Submit written comments by October 11, 1995. For the devices the 
agency is proposing to reclassify into class I and exempt from the 
requirement of premarket notification, FDA is proposing that any final 
rule that may issue based on this proposed rule become effective 30 
days after the date of its publication in the Federal Register.
FOR FURTHER INFORMATION CONTACT: Melpomeni K. Jeffries, Center for 
Devices and Radiological Health (HFZ-404), Food and Drug 
Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-
2186.

    In FR Doc. 95-18456, appearing on page 38902 in the Federal 
Register of Friday, July 28, 1995, the following corrections are made:
    1. On page 38902, in the third column, under the DATES caption, in 
the second sentence, ``August 28, 1995'' is corrected to read ``30 days 
after the date of its publication in the Federal Register.''
    2. On page 38906, in the first column, in Table 4.--ANESTHESIOLOGY 
DEVICES, ``868.1975 Water Vapor Analyzer'' is added after ``868.1870 
Gas volume calibrator''.

    Dated: August 28, 1995.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 95-21737 Filed 8-31-95; 8:45 am]
BILLING CODE 4160-01-F