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From:
U.S. Food and Drug Administration
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Learn if a Medical Device Has Been Cleared by FDA for Marketing | FDA
https://www.fda.gov/medical-devices/consumers-medical-devices/learn-if-medical-device-has-been-cleared-fda-marketing
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The regulatory classes for medical devices that are based on the degree of control necessary to assure the various types of devices are safe and effective.
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