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U.S. Department of Health and Human Services

510(k) Premarket Notification

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41 to 50 of 500 Results *
Decision Date To: 07/22/2019
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celerity hp chemical indicator, celerity vaporized vh2o2 process indicator adhesive label, verify v24 self-contained biological indicator vial label STERIS Corporation K192020 09/05/2019
centrimag acute circulatory support system Thoratec Corporation (now part of Abbott) K191557 07/10/2019
cepheid xpert sa nasal complete control panel Microbiologics, Inc. K191168 06/25/2019
clarus Carl Zeiss Meditec, Inc K191194 06/25/2019
confirm rx insertable cardiac monitor Abbott K192593 10/18/2019
conformis benefit hip system ConforMIS, Inc. K190904 08/28/2019
cortrak* 2 equilateral enteral access system Avanos Medical, Inc. K191340 06/04/2019
crc pc smart chamber k1 Capintec, Inc. K192199 09/12/2019
cs-series-fp radiographic / fluoroscopic systems with optional ca-100s / fluoroshield™ (roi assembly) Omega Medical Imaging, LLC K191713 10/04/2019
deflectable brush biopsy set Cook Incorporated K191485 06/26/2019

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