95-21095. Medical Devices; Premarket Notification (510(k)) Practices; Procedures/Good Manufacturing Practices/Compliance Program; Availability; Correction

[Federal Register Volume 60, Number 165 (Friday, August 25, 1995)]
[Notices]
[Page 44358]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-21095]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 95D-0114]


Medical Devices; Premarket Notification (510(k)) Practices; 
Procedures/Good Manufacturing Practices/Compliance Program; 
Availability; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; correction.

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SUMMARY: The Food and Drug Administration (FDA) is correcting a 
document that announced the availability of revisions to the standard 
compliance program for good manufacturing practices (GMP's) (Compliance 
Program 7382.830). The document was published in the Federal Register 
of June 20, 1995 (60 FR 32160). The document was published with an 
error in the telephone number for CDRH Facts on Demand. This document 
corrects that error.

FOR FURTHER INFORMATION CONTACT: Marquita B. Steadman, Center for 
Devices and Radiological Health (HFZ-84), Food and Drug Administration, 
2098 Gaither Rd., Rockville, MD 20850, 301-594-4765.

SUPPLEMENTARY INFORMATION: In FR Doc. 95-14947, appearing on page 32160 
in the Federal Register of June 20, 1995, the following correction is 
made:-
    In the second column, under the ``Addresses'' caption, in line 20, 
the telephone number ``1-800-899-0281'' for CDRH Facts on Demand is 
corrected to read ``1-800-899-0381''.

    Dated: August 17, 1995.
William K. Hubbard,
Acting Deputy Commissioner for Policy.
[FR Doc. 95-21095 Filed 8-24-95; 8:45 am]
BILLING CODE 4160-01-F