Guidance for the Content of Premarket Notifications for Urine Drainage Bags
Detailed guidance document from FDA and regulatory agencies.
Document Details
Guidance Document
June 7, 1994
March 17, 2020
a26b31d1-8be1-4748-800a-cf9a559eb4da
Related Documents
Color Additive Petitions - Medical Devices
Guidance DocumentJune 1, 1987Center for Devices and Radiological Health
Guidance for the Preparation of a Premarket Notification for Extended Laparoscopy Devices (ELD)
Guidance DocumentAugust 29, 1994Center for Devices and Radiological Health
Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Mechanical and Powered Wheelchairs, and Motorized Three-Wheeled Vehicles
Guidance DocumentJuly 25, 1995Center for Devices and Radiological Health
Quick Actions
Transform Regulatory Data into Actionable Intelligence
Join leading pharmaceutical and medical device companies who trust GKS for their regulatory compliance needs.
Try KeyPedia Today
Explore our real use cases and discover our features in depth.
Subscribe to our newsletter
Get the latest updates and insights delivered to your inbox