Document Detail

Who owns the 510(k)?
MedLine Citation:
PMID:  18605288     Owner:  NLM     Status:  MEDLINE    
Unfortunately, some medical device manufacturers, particularly those based outside the United States (US) are unaware of the business implications of submitting a 510(k) premarket notification to the US Food and Drug Administration. This article discusses information regarding the ownership and other business related aspects of filing a 510(k).
Maria E Donawa
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Medical device technology     Volume:  19     ISSN:  1048-6690     ISO Abbreviation:  Med Device Technol     Publication Date:    2008 Mar-Apr
Date Detail:
Created Date:  2008-07-07     Completed Date:  2008-08-26     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9215490     Medline TA:  Med Device Technol     Country:  England    
Other Details:
Languages:  eng     Pagination:  26, 28-9     Citation Subset:  T    
Donawa Consulting, Rome, Italy.
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MeSH Terms
Device Approval*
Marketing / legislation & jurisprudence*
Ownership / legislation & jurisprudence*
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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