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/K09 o-c05 Diagnostics Pty Ltd Spec Ultrasound System, 5 10(k) 510(k) Summary 1. Sponsor: MAY 7, 2009, Diagnostics Pty Ltd Lot 1, 40 – 46 West Barton Road PO Box 736, Mooresville Barton, SA 5031
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What is k090505 - fda?
K090505 is a specific code assigned by the FDA to a particular medical device application.
Who is required to file k090505 - fda?
The manufacturer or sponsor of the medical device is required to file a k090505 - fda application.
How to fill out k090505 - fda?
The k090505 - fda application must be filled out with detailed information about the medical device, its intended use, and any relevant clinical data.
What is the purpose of k090505 - fda?
The purpose of k090505 - fda is to seek approval from the FDA to market a specific medical device.
What information must be reported on k090505 - fda?
The k090505 - fda application must include information about the medical device's design, materials, intended use, and any relevant clinical data.
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