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K132290 Page 1 of 3 APR 10 2014 510(k) Summary Submitter information Company name Establishment registration number Street Address City Postal code Country Phone number Fax number Contact name Contact
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Who needs k132290 - fda home?
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What is k132290 - fda home?
k132290 - fda home is a form required by the FDA for reporting certain information about medical devices.
Who is required to file k132290 - fda home?
Manufacturers, importers, and device user facilities are required to file k132290 - fda home.
How to fill out k132290 - fda home?
k132290 - fda home can be filled out online through the FDA's Electronic Submissions Gateway.
What is the purpose of k132290 - fda home?
The purpose of k132290 - fda home is to track and monitor medical devices to ensure safety and effectiveness.
What information must be reported on k132290 - fda home?
Information such as device identification, adverse events, and enhancements must be reported on k132290 - fda home.
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