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Pavilion 6 MAY) 510 (k) SUMMARY AS REQUIRED BY SECTION 807.92 Manufacturer & Submitter: Contact: Phamatech Inc. 10151 Barnes Canyon Road San Diego, California 92121, USA Carl A. Mongol Vice President
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How to fill out manufacturer amp submitter:
01
Start by entering the name and contact information of the manufacturer or company responsible for the product or service being submitted.
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Include any additional details that may be required, such as the manufacturer's address, phone number, and email address.
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Provide a brief description of the product or service being submitted, including any relevant specifications or features.
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Include any necessary documentation or supporting materials, such as product manuals, certificates of compliance, or test reports.
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Review the manufacturer amp submitter form for accuracy and completeness before submitting it.
Who needs manufacturer amp submitter:
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Manufacturers or companies responsible for creating and producing products or services often need to fill out a manufacturer amp submitter form. This form helps them provide detailed information about their products or services to regulatory authorities, customers, or other stakeholders.
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What is manufacturer amp submitter?
Manufacturer amp submitter refers to the entity responsible for submitting information about a product or device to the appropriate regulatory agency.
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The manufacturer or distributor of a product or device is typically required to file manufacturer amp submitter.
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Manufacturer amp submitter can usually be filled out electronically on the regulatory agency's website or through a designated portal.
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The purpose of manufacturer amp submitter is to provide the regulatory agency with information about the product or device, including its safety, efficacy, and intended use.
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Information such as product name, manufacturer details, device classification, intended use, and any adverse events must be reported on manufacturer amp submitter.
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