Document Detail

Ear, nose, and throat devices; classification of the nasal dilator, the intranasal splint, and the bone particle collector. Food and Drug Administration, HHS. Final rule.
MedLine Citation:
PMID:  10557619     Owner:  NLM     Status:  MEDLINE    
The Food and Drug Administration (FDA) is classifying the nasal dilator, intranasal splint, and the bone particle collector into class I (general controls). FDA is also exempting the devices from the requirements of premarket notification. This action is taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976 (the amendments), the Safe Medical Devices Act of 1990 (SMDA), and the Food and Drug Administration Modernization Act of 1997 (FDAMA).
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Federal register     Volume:  64     ISSN:  0097-6326     ISO Abbreviation:  Fed Regist     Publication Date:  1999 Mar 
Date Detail:
Created Date:  1999-09-30     Completed Date:  1999-09-30     Revised Date:  2004-11-17    
Medline Journal Info:
Nlm Unique ID:  7808722     Medline TA:  Fed Regist     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  10947-9     Citation Subset:  T    
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MeSH Terms
Bone and Bones
Device Approval
Dilatation / classification*,  instrumentation
Equipment Design
Equipment Safety
Filtration / instrumentation
Nasal Obstruction / therapy
Splints / classification*
United States
United States Food and Drug Administration

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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