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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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mjolnir pro. (multi–electrode plasma) Shenzhen Leaflife Technology Co., Ltd k233760 02/20/2024
lyher® urine multi-drug test kit(cup), lyher® urine multi-drug test kit(cassette), lyher® urine multi-drug test kit(dipcard) Hangzhou Laihe Biotech Co., Ltd. k232597 01/09/2024
autoscore Holberg EEG AS k231068 01/07/2024
millipede 088 access catheter Perfuze Ltd. k233648 12/14/2023
pmd clean acne, model: 4004-cablue-na, 4004-grey-na, 4004-yellow-na, 4004-psto-na, 4004-lpur-na, 4004-cablue-na-int, 4004-grey-int, 4004-yellow-int, 4004-psto-int, 4004-lpur-int Dongguan Hunter Electronic Technology Co., Ltd. k230490 10/27/2023
encor enspire™breast biopsy system (e4115, e4230); encor™ breast biopsy driver (drencor); encor™ mri breast biopsy driver (drencormr); encor™ breast biopsy driver probes (ecp017g, ecp017gv, ecp0110g, ecp0110gv, ecp0112g, ecp0112gv); encor™ mri breast biopsy probes (ecpmr017g, ecpmr0110g, ecpmr0110g SenoRx, Inc. k233220 10/27/2023
molli 2 MOLLI Surgical, Inc. k231579 10/26/2023
vitek 2 ast-streptococcus penicillin (<=0.06 - =>8 µg/ml), vitek 2 streptococcus penicillin (<=0.06 - >=8 µg/ml), vitek 2 streptococcus penicillin bioMerieux, Inc k232201 10/23/2023
vyspan™ pct system Vy Spine, LLC k232167 09/27/2023
led spectrum therapy instrument Shenzhenshi Sincoheren S&T Development Co.,Ltd. k231894 09/20/2023

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