Regulatory Docs

Mercury-Added Product Information
In accordance with the notification requirements for mercury-added product enacted
by the states of Connecticut, Maine, Massachusetts, New Hampshire, New York, Rhode
Island, and Vermont.

The 510(k) pre-market notification process is the most common method used in the
United States for describing the design and manufacture of medical devices which the
US Food and Drug Administration (FDA) uses to determine a "substantial equivalence"
decision to authorize marketing of a medical device within the United States.

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