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May 22, 2012 ... barcodes on patient wristbands to blood specimen orders received from the ... patient's wristband as well as information from the label on the ...

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What is new 510k template?

The new 510k template is a standardized format for submitting a premarket notification to the FDA for certain medical devices.

Who is required to file new 510k template?

Manufacturers of certain medical devices are required to file the new 510k template when seeking FDA approval.

How to fill out new 510k template?

The new 510k template can be filled out electronically on the FDA's website or through a third-party electronic submission system.

What is the purpose of new 510k template?

The purpose of the new 510k template is to provide the FDA with information about a medical device's safety and effectiveness.

What information must be reported on new 510k template?

The new 510k template requires information about the device's intended use, design, materials, testing, and labeling.

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