fda-device · Food and Drug Administration · Rule · Published 2004-03-05 · Effective 2004-03-05 · 69 FR 10331
Document
Document number
04-4887
Federal Register citation
69 FR 10331
CFR reference
21 CFR 882
Type
Rule
Action
Final rule; technical amendment.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2004-03-05
Effective date
2004-03-05
Abstract
The Food and Drug Administration (FDA) is correcting a neurological device classification regulation. FDA is changing the name of the device from "cottonoid paddie" to "neurosurgical paddie." FDA is making this change because interested persons have advised FDA that the word "cottonoid" is a registered trademark and its use has created problems for competitors of the company that has registered the trademark. FDA is also removing the word "cotton" from the identification because devices of this type are not always made of cotton.