Medical device; exemption from premarket notification; class II devices; barium enema retention catheters and tips with or without a bag.  Food and Drug Administration, HHS.  Final rule.
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).
D001466:Barium Sulfate; D002404:Catheterization / Q000145:classification / Q000295:instrumentation*; D018795:Device Approval; D004733:Enema / Q000295:instrumentation*; D004867:Equipment Design; D004869:Equipment Safety; D006801:Humans; D014481:United States; D014486:United States Food and Drug Administration
D001466:Barium Sulfate