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U.S. Department of Health and Human Services

510(K) Premarket Notification

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Device Name
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510(K)
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microscan dried gram positive mic/combo panels with vancomycin (0.25-64 mcg/ml) Siemens Healthcare Diagnostics Inc. k150039 07/02/2015
nitrile powder free examination glove with colloidal oatmeal usp skin protectant - white, nitrile powder free examination glove with colloidal oatmeal usp skin protectant - dawn blue, nitrile powder free examination glove with colloidal oatmeal usp skin protectant - dark blue (dkbu), nitrile powder free examination glove with colloidal oatmeal usp skin protectant - dark violet blue (dvbu) HARTALEGA NGC SDN. BHD. k150110 04/23/2015
comborehab SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD. k150436 11/13/2015
cellfina system ULTHERA, INC. k150505 07/29/2015
breast pump Guangzhou Jinxinbao Electronic Co.,Ltd k150923 11/06/2015
vios monitoring system VIOS MEDICAL, INC. k150992 12/16/2015
positron emission tomography (pet) and computed tomography (ct) system, positron emission tomography (pet) and computed tomography (ct) system NEUSOFT MEDICAL SYSTEMS CO., LTD. k151403 11/02/2015
endoplus hand-held laparoscopic instruments ENDOPLUS k151567 12/23/2015
gemmed pedicle screw spinal system SUZHOU GEMMED MEDICAL INSTRUMENT CO., LTD. k151592 09/24/2015
pacendo sodium hyprochlorite PAC-DENT INTERNATIONAL, INC. k151852 11/10/2015

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