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510(k) SummaryMA2300
As Required by 21 sections 807.92 (c)
1Submitter Name: WINS TECHNOLOGY CO., LTD
2Address: 3F YounbgPunlg BID, #2251 Poison
KangnamKu, Seoul, Korea
3Phone: 8225293785
4Fax: 8225723784
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Question: How to fill out 510k summaryma2300 - food? Who needs 510k summaryma2300 - food?
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Begin by reviewing the requirements and guidelines provided by the FDA for submitting a 510k summaryma2300 for a food-related product.
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Create a summary of the product's intended use, indications for use, and the technological characteristics that make it substantially equivalent to already approved products.
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Food manufacturers who are introducing a new food-related product to the market that has not been previously approved by the FDA.
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What is 510k summaryma2300 - food?
510k summaryma2300 - food is a summary of the information submitted to the FDA regarding a food related medical device or product.
Who is required to file 510k summaryma2300 - food?
Manufacturers of food related medical devices or products are required to file 510k summaryma2300.
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To fill out 510k summaryma2300 - food, manufacturers need to provide detailed information about the safety and effectiveness of the product.
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The purpose of 510k summaryma2300 - food is to demonstrate to the FDA that the food related medical device or product is substantially equivalent to a device or product that is already legally marketed.
What information must be reported on 510k summaryma2300 - food?
Information such as device description, intended use, technological characteristics, performance data, and labeling must be reported on 510k summaryma2300 - food.
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