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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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BK120030 Statement

510(k) Statement

I certify that, in my capacity as Executive Vice President of Healthcare-ID, Inc., 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.

Signed: /signature/

Name: Bryan Sadorf

Title: Executive Vice President