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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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BK120051 510(k) Truth and Accuracy Statement

I certify that, in my capacity as the Chief Executive Officer of Data Innovations LLC I believe to the best of my knowledge, that all data and information submitted in the premarket notification are truthful and accurate and that no material fact has been omitted.

I will make available all information included in this premarket notification on safety and effectiveness within 30 days of request by any person if the device described in the premarket notification submission is determined to be substantially equivalent. The information I agree to make available will be a duplicate of the premarket notification submission, including any adverse safety and effectiveness information, but excluding all patient identifiers, and trade secret and confidential commercial information, as defined in 21 CFR 20.61.

/s/

Michael F. Epple                 Date: 8/22/12
Chief Executive icer
Data Innovations LLC