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Regulatory Information
1998_register
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2010-09-24
article
Medical Devices; Exemptions From Premarket Notification; Class II Devices
Notices
D09002ee1bdfebe7c
D09002ee1bdfebf10
United States
Department of Health and Human Services
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org
United States Government Agency or Subagency
United States
Food and Drug Administration
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org
United States Government Agency or Subagency
The Food and Drug Administration (FDA) is publishing notice of a petition requesting exemption from the premarket notification requirements for a class II device, the audiometer. FDA is publishing this notice in order to obtain comments on this petition in accordance with procedures established by the Food and Drug Administration Modernization Act of 1997 (FDAMA).
63 FR 64091
https://www.govinfo.gov/app/details/FR-1998-11-18/98-30813
98-30813
fr18no98-99
4160-01-F
Docket No. 98P-0833
https://www.govinfo.gov/app/details/FR-1998-11-18/98-30813
https://www.govinfo.gov/content/pkg/FR-1998-11-18/html/98-30813.htm
https://www.govinfo.gov/content/pkg/FR-1998-11-18/pdf/98-30813.pdf
2 p.
64091
64092
63 FR 64091
Medical Devices; Exemptions From Premarket Notification; Class II Devices; Federal Register Vol. 63, Issue
NOTICE
98-30813
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
1998-12-18
Docket No. 98P-0833
4160-01-F
98-30813
Notice.
The Food and Drug Administration (FDA) is publishing notice of a petition requesting exemption from the premarket notification requirements for a class II device, the audiometer. FDA is publishing this notice in order to obtain comments on this petition in accordance with procedures established by the Food and Drug Administration Modernization Act of 1997 (FDAMA).
Written comments by December 18, 1998.
Heather S. Rosecrans, Center for Devices and Radiological Health (HFZ-404), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594- 1190.
Federal Register
Vol. 63, no. 222
Office of the Federal Register, National Archives and Records Administration
1998-11-18
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210 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-1998-11-18
P0b002ee180a64e5e
0097-6326
0042-1219
0364-1406
769-004-00000-9
000582072
f:fr18no98
https://www.govinfo.gov/app/details/FR-1998-11-18
https://www.govinfo.gov/content/pkg/FR-1998-11-18/pdf/FR-1998-11-18.pdf
fdlp
63969
64168
DGPO
2010-09-24
2023-05-06
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FR
FR-1998-11-18
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