Medical Device; Exemption From Premarket Notification; Class II Devices; Barium Enema Retention Catheters and Tips With or Without a Bag
Information
Type
Rule
Regulated products
Medical Devices
Published
December 8, 2000
Last updated
December 8, 2000
Description
Document number 00-31292. The Food and Drug Administration (FDA) is publishing an order granting a petition requesting exemption from the premarket notification requirements for barium enema retention catheters and tips with or without a bag with certain limitations. This rule will exempt from premarket notification barium enema retention catheters and tips with or without a bag. FDA is publishing this order in accordance with procedures established by the Food and Drug Administration Modernization Act of 1997 (FDAMA).
Tags
Organization
Country / Region
United States
License
Other (Public Domain)