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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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sonata breastpump deluxe, sonata warranty breastpump, double pumping tubing kit, retail, connector spare parts kit, silicone membrane, retail, power adaptor, retail MEDELA, INC k161725 10/28/2016
ips casedesigner NOBEL BIOCARE AB k161634 11/10/2016
careview 750cw/750c x-ray flat panel detectors CARERAY DIGITAL MEDICAL SYSTEM CO., LTD. k163019 12/01/2016
comfortguard plus surgical gown, i500, comfortguard surgical gown, i500 GRI MEDICAL & ELECTRICAL TECHNOLOGY CO., LTD. k162442 12/12/2016
syngo application software SIEMENS MEDICAL SOLUTION USA, INC. k163285 02/14/2017
illumiflow laser cap EGLOBAL, LLC k162071 02/24/2017
jac-cell medic testers JAC-CELL MEDIC k170105 02/28/2017
spectra 9plus Uzinmedicare Company k162415 03/15/2017
biopsy forceps Fehling Instruments GmbH & Co. KG k170726 06/02/2017
bi-funnel and tri-funnel gastrostomy feeding tubes with enfit connection, entuit gastrostomy br balloon retention feeding tube with enfit connection Xeridiem Medical Devices k171347 06/06/2017

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