95-7512. Medical Devices; Exemptions From Premarket Notification for Certain Classified Devices; Correction

[Federal Register Volume 60, Number 59 (Tuesday, March 28, 1995)]
[Rules and Regulations]
[Page 15872]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-7512]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 886

[Docket No. 94M-0260]


Medical Devices; Exemptions From Premarket Notification for 
Certain Classified Devices; 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 December 7, 1994 (59 FR 
63005). The document exempted 148 generic types of class I devices from 
the requirement of premarket notification, with limitations. The 
document was published with an error in the codified section. This 
document corrects that error.
EFFECTIVE DATE: January 6, 1995.

FOR FURTHER INFORMATION CONTACT: Joseph M. Sheehan, Center for Devices 
and Radiological Health (HFZ-84), Food and Drug Administration, 2094 
Gaither Rd., Rockville, MD 20850, 301-594-4765, ext. 157.
    In FR Doc. 94-30025, appearing on page 63005 in the Federal 
Register of Wednesday, December 7, 1994, the following correction is 
made:


Sec.  886.4350  [Corrected]

    On page 63013, in the third column, in Sec. 886.4350, paragraph (b) 
is corrected by removing the words ``only when the device meets the 
ANSI standard on optic radiation limits.''

    Dated: March 17, 1995.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 95-7512 Filed 3-27-95; 8:45 am]
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