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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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Decision
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steritec green card pack bowie-dick test Steritec Products Mfg Co, Inc. k132372 11/26/2013
subdural electrode, strip/intraoperative strip, grid/intraoperative grid, multi-strip and split grid, intraoperative mapping grid Spes Medica Srl k211954 11/10/2022
suboccipital ice pillow Ferguson Medical k882413 11/30/1988
superflab Mick Radio-Nuclear Instruments, Inc. k812893 12/08/1981
surefire 10 Argen Precious Metals, Inc. k940282 03/04/1994
surgical instrument pouch #m102 Pro-Safe Professional Linens, Inc. k891213 04/14/1989
synchron control Beckman Coulter, Inc. k003488 11/27/2000
synchron systems phosphorus (phs) reagent Beckman Coulter, Inc. k041643 08/18/2004
synermed cholesterol reagent kit Synermed, Inc. k903015 10/01/1990
syngo perfusion-ct Siemens AG Medical Solutions k033832 12/23/2003

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