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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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stryker antimic catheter STRYKER INSTRUMENTS, INSTRUMENTS DIV. k072702 03/19/2008
ivas 2-10mm (10 gauge) balloon catheter, ivas 2-15 mm(10 gauge)0705-115-500, ivas 3-10mm(8 gauge)balloon catheter, ivas STRYKER INSTRUMENTS, INSTRUMENTS DIV. k093419 03/18/2010
dekompressor percutaneous discectomy probe STRYKER INSTRUMENTS k032473 11/07/2003
pur dental implant system STERNGOLD DENTAL, LLC k151928 11/06/2015
emu-graph 4 emulator, model ci 144 STERITEC PRODUCTS, INC. k083650 03/05/2009
verify chemical monitoring strip for resert soultions (resert xl test strip version 2) STERIS Corporation k102296 02/09/2011
smartband emr kit (sb-emr-k, sb-emr-k-12, sb-emr-k-9.4), smartband emr pack (sb-emr-p, sb-emr-p-12, sb-emr-p-9.4), smartsnare emr hexagonal snare (ss-230-1 or packaged with kit) Steris Corporation k212860 10/07/2021
disposable safety lancet (impress); disposable safety lancet (impress pro); disposable safety lancet (lite4); disposable blood lancet (elite); disposable blood lancet (elite pro) SteriLance Medical (Suzhou) Inc. k233796 01/16/2024
percutaneous sheath intro. kit or tray STANCO MEDICAL, INC. k792172 11/13/1979
stackhouse smoke evacuator, models st-3000, st 3100 STACKHOUSE, INC. k001082 06/15/2000

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