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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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stony brook surgical innovaions sterna-wire (sternal sutures) STONY BROOK SURGICAL INNOVATIONS, INC. k013059 10/22/2001
stress test system QUINTON, INC. k780166 02/21/1978
sublime radial access 018 rx dilatation catheter Creagh Medical Ltd. (a wholly owned subsidiary of Surmodics, k211044 06/16/2021
sun-rain ultrasonic therapy models, su-300, su-400, su-500, su-600, su-700, su-800, su-900 SUN-RAIN SYSTEM CORP. k090542 10/23/2009
super-sorber HOME HEALTHCARE PRODUCTS, INC. k780938 12/15/1978
suresigns vs2 vital signs monitor, suresigns vm1 patient monitor, suresigns vs3 cital signs monitor PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO. k082280 10/08/2008
surgicraft screw fixation system SURGICRAFT LTD. k080447 06/13/2008
swiftmr AIRS Medical Inc. k220416 05/25/2022
swiss lithobreaker EMS ELECTRO MEDICAL SYSTEMS SA k123038 01/16/2013
sydney ivf culture oil William A. Cook Australia Pty Ltd k170257 02/24/2017

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