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$ 5J/ 13 510(K) SUMMARY This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SODA 1990 and 21 CFR 807.92. The assigned 510(k) number

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Who needs k133411 - fda?

1. Individuals or organizations working in the pharmaceutical or healthcare industry may require k133411 - fda. This form may be specifically relevant to those involved in the development, manufacturing, or distribution of medical devices or drugs.
2. Companies or individuals seeking approval or clearance from the FDA (U.S. Food and Drug Administration) for a particular medical device, drug, or related process may need to fill out k133411 - fda.
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What is k133411 - fda?

k133411 - fda is a form required by the FDA for certain medical devices.

Who is required to file k133411 - fda?

Manufacturers, importers, and device user facilities are required to file k133411 - fda.

How to fill out k133411 - fda?

k133411 - fda can be filled out electronically on the FDA's website or submitted via mail.

What is the purpose of k133411 - fda?

The purpose of k133411 - fda is to provide the FDA with information about medical devices on the market.

What information must be reported on k133411 - fda?

Information such as device identification, adverse events, and manufacturing changes must be reported on k133411 - fda.

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