https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-content-premarket-notification-510k-submissions-piston-syringes
This document establishes the 510(k) review requirements for piston syringes.
on thepremarket notificationguidancecontentsubmissions
https://www.mlo-online.com/molecular/mdx/news/55332608/diasorin-submits-fda-premarket-notification-for-liaison-plex-gastrointestinal-flex-assay
Diasorin has filed a 510(k) premarket notification with the FDA for its LIAISON PLEX Gastrointestinal Flex Assay, a versatile tool designed to enhance...
premarket notificationdiasorinsubmitsfdaliaison
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/dental-composite-resin-devices-premarket-notification-510k-submissions-guidance-industry-and-fda
Assists industry in preparing premarket notification submissions (510(k)s) for composite restorative resins used in dentistry.
dental compositepremarket notificationresindevicessubmissions
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/recommendations-use-clinical-data-premarket-notification-510k-submissions
This guidance provides information for situations when clinical data may be necessary to demonstrate substantial equivalence in a 510(k) submission.
premarket notificationrecommendationsuseclinicaldata