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DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION DISTRICT ACTRESS AHO PHONE NUMERATE(S) OF INSPECTION250 Marquette Ave, Ste. 600 Minneapolis, MN 55401 612)3344100 Fax: 612)3344134FEJNUMBER2/22/20183/7/2018* 2131125NAME
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Devicemaker Sybaritic is flagged for compliance and reporting issues related to medical devices that may pose health risks or fail to meet regulatory standards.
Manufacturers and importers of medical devices that are flagged as sybaritic are required to file the relevant reports and documentation.
To fill out the devicemaker sybaritic flagged form, follow the provided guidelines, ensuring all sections are completed with accurate and detailed information regarding device specifications and compliance status.
The purpose of devicemaker sybaritic flagged is to ensure safety and efficacy of medical devices by mandating reporting of potential risks and compliance with regulatory requirements.
Information that must be reported includes device identification, manufacturing details, compliance status, incident reports, and corrective actions taken.
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