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U.S. Department of Health and Human Services

510(K) Premarket Notification

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510(K)
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Decision
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gsp neonatal total galactose kit PerkinElmer Inc. k190335 11/06/2019
125-i labeled human luteinizing hormone PCL-RIA, INC. k780576 05/19/1978
pasco mic and mic/id panels PASCO LABORATORIES, INC. k010508 04/23/2001
pajunk's kit for balloon aided laparoscopy PAJUNK GMBH MEDIZINTECHNOLOGIE k080654 05/08/2008
pacing leads model ul-811 and ul-813 PACESETTER SYSTEMS k781776 10/27/1978
cooked meat medium OXOID U.S.A., INC. k813232 12/03/1981
biosomnia-v3 OXFORD BIOSIGNALS LIMITED k042309 09/08/2004
mini-osteo pedicle fixation system OSTEOMED Indústria e Comércio de Implantes LTDA k231443 11/21/2023
tsiii ba fixture OSSTEM IMPLANT Co., Ltd. k163088 04/21/2017
estar-z Osstem Implant Co., Ltd. k210097 07/02/2021

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