Document Detail

Medical device; exemption from premarket notification; class II devices; barium enema retention catheters and tips with or without a bag. Food and Drug Administration, HHS. Final rule.
MedLine Citation:
PMID:  11503724     Owner:  NLM     Status:  MEDLINE    
The Food and Drug Administration (FDA) is publishing an order granting a petition requesting exemption from the premarket notification requirements for barium enema retention catheters and tips with or without a bag with certain limitations. This rule will exempt from premarket notification barium enema retention catheters and tips with or without a bag. FDA is publishing this order in accordance with procedures established by 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:  65     ISSN:  0097-6326     ISO Abbreviation:  Fed Regist     Publication Date:  2000 Dec 
Date Detail:
Created Date:  2001-05-29     Completed Date:  2001-05-29     Revised Date:  2004-11-17    
Medline Journal Info:
Nlm Unique ID:  7808722     Medline TA:  Fed Regist     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  76930-2     Citation Subset:  T    
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MeSH Terms
Barium Sulfate / diagnostic use
Catheterization / classification,  instrumentation*
Device Approval*
Enema / instrumentation*
Equipment Design
Equipment Safety
United States
United States Food and Drug Administration
Reg. No./Substance:
7727-43-7/Barium Sulfate

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

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