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U.S. Department of Health and Human Services

510(k) Premarket Notification

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ProductCode: KYI Applicant: ASCENSION ORTHOPEDICS, INC. Decision Date To: 03/29/2024
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ascension pyrohemisphere, models phs-440-10, phs-440-20, phs-440-30, phs-440-40, phs-440-50 ASCENSION ORTHOPEDICS, INC. K041451 08/25/2004
ascension pyrosphere (pcs) ASCENSION ORTHOPEDICS, INC. K042690 11/13/2004
ascension, models cmc-400,13,cmc-400-20,cmc-400-30,cmc-400-40 ASCENSION ORTHOPEDICS, INC. K061451 08/11/2006
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