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Matt Clausen One Medline Place Mundelein IL 60060-4486 September 26 2014 Re K140369 Trade/Device Name Medline Neuro Sponge Regulation Number 21 CFR 882. Fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also please note the regulation entitled sMisbranding by reference to premarket notifications 21CFR Part 807. Type of Use Select one or both as applicable Prescription Use Part 21 CFR 801 Subpart D Over-The-Counter Use 21 CFR 801 Subpart C CONTINUE ON A SEPARATE PAGE IF NEEDED. 510...
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What is one medline place?
One Medline Place is a physical address designated specifically for submitting medical device reports.
Who is required to file one medline place?
Manufacturers, importers, and device user facilities are required to file One Medline Place.
How to fill out one medline place?
To fill out One Medline Place, you need to provide specific information about the medical device and any adverse events associated with it.
What is the purpose of one medline place?
The purpose of One Medline Place is to ensure that all medical device reports are submitted to the FDA in a timely manner.
What information must be reported on one medline place?
Information such as the device identifier, type of adverse event, and any actions taken in response to the event must be reported on One Medline Place.
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