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U.S. Department of Health and Human Services

510(k) Premarket Notification

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ProductCode: DTN Applicant: AVECOR CARDIOVASCULAR, INC. Decision Date To: 12/02/2022
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myotherm (tm) xp cardioplegia delivery system AVECOR CARDIOVASCULAR, INC. K971105 07/11/1997
affinity cvr AVECOR CARDIOVASCULAR, INC. K936003 06/20/1994
affinity venous reservior bag AVECOR CARDIOVASCULAR, INC. K935717 05/10/1994
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