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U.S. Department of Health and Human Services

510(k) Premarket Notification

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ProductCode: DYB Applicant: BAYLIS MEDICAL CO., INC Decision Date To: 02/21/2017
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torflex transseptal guiding sheath BAYLIS MEDICAL CO., INC. K102948 04/01/2011
sureflex steerable guiding sheath kit BAYLIS MEDICAL CO., INC. K122926 01/24/2013
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