Substantially Equivalent 510(k) Device Information
Applicant: Digi-Trax Corporation Buffalo Grove, IL
510(k) number: BK000020
Product: Digi-Trax Donor-ID 2.0
Date: 4/20/2000
Summary of Safety and Effectiveness
510(k) Statement
I certify that, in my capacity as President of Digi-Trax, 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.
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Name: Richard Kriozere
Title: President
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