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U.S. Department of Health and Human Services

510(K) Premarket Notification
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st.jude medical mediguide enabled livewire steerable electrophysiology catheter, livewire electrophysiology catheter, response electrophysiology catheter with lumen, response electrophysiology catheter and sjm epicardial catheter system, supreme electrophysiology catheter St. Jude Medical k151622 07/15/2015
durex play lubricant SSL AMERICAS, INC. k032124 01/16/2004
rampart-o, rampart-t SPINEOLOGY, INC. k132053 09/16/2013
staxx fx system SPINE WAVE, INC. k053336 07/03/2006
mercury spinal system Spinal Elements Inc. k151215 06/03/2015
clearblue® early digital pregnancy test SPD Swiss Precision Diagnostics GmbH k200913 08/13/2021
6ms invisible aligner SMS OPCO, LLC k210652 06/02/2021
normoflo irrigation fluid warmer, models h-1100, h-1129, normoflo irrigation warming set, models, ir-40, ir-500, ir-600, SMITHS MEDICAL ASD, INC. k072080 06/02/2008
level 1 snuggle warm adult underbody convective warming blanket, model sw-2013, level 1 snuggle warm left lateral SMITHS MEDICAL ASD, INC. k083336 06/03/2009
plus chem, determination of ld (ldh-p) SMITH KLINE DIAGNOSTICS, INC. k791085 07/17/1979

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