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AUG 2 4 2004Denimed Electr6nica
Equipments Odontol6gicosAyto 25, 2004510(k) Summary
Applicant:.)chained Electronica
BV. De LDS Ale manes 3485 Los Boulevard
X5022EOG C6rdobaArgentina
I/l & :Fax: (0351)
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What is furls device registration ampampampamp?
FURLS stands for FDA Unified Registration and Listing System. It is a system used by medical device establishments to register their devices with the FDA and submit required information.
Who is required to file furls device registration ampampampamp?
All medical device establishments that manufacture, prepare, propagate, compound, or process medical devices for commercial distribution in the United States are required to file a furls device registration.
How to fill out furls device registration ampampampamp?
To fill out the furls device registration, establishments need to access the FDA Unified Registration and Listing System (FURLS) website, create an account, and complete the registration form with the required information about their establishment and medical devices.
What is the purpose of furls device registration ampampampamp?
The purpose of furls device registration is to provide the FDA with accurate and up-to-date information about medical device establishments and the devices they distribute in order to ensure regulatory compliance and facilitate effective post-market surveillance.
What information must be reported on furls device registration ampampampamp?
The furls device registration requires establishments to provide information such as establishment name, contact information, owner/operators details, device listing information, manufacturing activities, and compliance with other applicable regulations.
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