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AFFIDAVIT Maryland State Board of Dental ExaminersCLASS I, CLASS II, AND CLASS III ANESTHESIA AND SEDATION PERMIT HOLDERS An applicant for the renewal of a Class I, Class II, or Class III Anesthesia
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What is CLASS I, CLASS II, AND CLASS III ANESTHESIA AND SEDATION PERMIT HOLDERS Form?

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Class I and Class II refer to different levels of medical devices based on their risk level. Class I devices have the lowest risk level and include items such as bandages, examination gloves, and hand-held surgical instruments. Class II devices have a higher risk level and include items such as infusion pumps, powered wheelchairs, and surgical drapes.
Manufacturers, distributors, and importers of medical devices are required to file Class I and Class II devices with the appropriate regulatory agency.
To fill out Class I and Class II device filings, manufacturers, distributors, and importers must provide information such as device description, intended use, risk assessment, labeling, and performance data.
The purpose of Class I and Class II classifications is to ensure the safety and effectiveness of medical devices in the market by assessing their risk level and establishing regulatory requirements.
Information that must be reported on Class I and Class II device filings include device description, intended use, risk assessment, labeling, performance data, and any adverse events.
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