About: http://webisa.webdatacommons.org/405841255

Property	Value
http://www.w3.org/1999/02/22-rdf-syntax-ns#type	http://www.w3.org/ns/prov#Entity
http://www.w3.org/ns/prov#value	She said modifications to 510(k)-cleared devices are often not submitted to the agency unless they are changes that could significantly affect safety or effectiveness or there is a modification to the intended use.
http://www.w3.org/ns/prov#wasQuotedFrom	mddionline.com