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Tests were also carried out to satisfy the requirements of the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices and lEC 62304 Medical Device Software - Life Cycle Process. 510 K SUBMISSION PREMARKET NOTIFICATION ROSA SURGICAL DEVICE Page 6 of 45 SUMMAY As Required by 21 CFR 807. 92 Summary of Safety and Effectiveness I Submitter MedTech S*A Parc Eurom decine B5timent 8 SEP 2 3 2010 1006 rue de la Croix Verte 34090 Montpellier France Contact...
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