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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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hs70a diagnostic ultrasound system Samsung Medison Co., Ltd. k173713 03/08/2018
hunter scientific injection pipettes HUNTER SCIENTIFIC LIMITED k001615 08/18/2000
identity imprint knee replacement system (including identity imprint posterior stabilized (ps) krs and identity imprint cruciate retaining (cr) krs) Conformis Inc. k221404 07/26/2022
ihelmet hair growth system Slinph Technologies Co., LTD k190467 12/26/2019
imagepilot Konica Minolta, Inc. k210066 05/06/2021
immulite: 2000 free t4 calibration verification material, 2000 igf-i calibration verification material, 2000 prolactin c Siemens Healthcare Diagnostics Inc. k140818 05/01/2014
immunalysis cannabinoids urine enzyme immunoassay, immunalysis cthc urine calibrators, immunalysis cthc urine control set IMMUNALYSIS CORPORATION k151203 06/05/2015
imt.lab PIE MEDICAL k043360 01/05/2005
inarex, model 2d-lx INAREX CORPORATION k080554 08/27/2008
indigo aspiration system - aspiration catheter 12 and separator 12 Penumbra, Inc. k202821 11/18/2020

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