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PRE MARKET NOTIFICATION 510 (K)

Some Class I and most Class II devices require a 510(k). In a 510(k), the sponsor must demonstrate that the new device is “substantially equivalent” to a predicate device in terms of intended use, technological characteristics, and performance testing, as needed.

We provide complete assistance for Pre-Market Notification 510(k), at highly competitive fees. Please contact us for more information.

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