Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery
Posts tagged as “510(k)”
Bone Anchors – Premarket Notification (510(k)) Submissions
FDA eSTAR Pilot Program
Medical Devices; Exemption From Premarket Notification; Class II Devices; Powered Wheeled Stretcher
Medical Devices; Exemptions From Premarket Notification for Class I and Class II Devices
Ear, Nose, and Throat Devices; Classification of the Self-Fitting Air-Conduction Hearing Aid
Special Premarket Notification [510(k)] Pathway
Guidance Refuse to Accept Policy for 510(k)s
Intent to Exempt Certain Unclassified Medical Devices from Premarket Notification Requirements