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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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Applicant
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510(K)
Number
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Decision
Date
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radiodexter, dextroscope, dextrobeam, models 1.0, mk10, mk3 & mk4 VOLUME INTERACTIONS PTE LTD k071054 05/22/2007
4 fr single lumen (sl) powerpicc catheter C.R. BARD, INC. k070996 05/08/2007
philips reusable spo2 sensors m1191t, m1192t and m1193t, clip sensor m1196t and disposable spo2 sensors m1131a, m1132a PHILIPS MEDICAL SYSTEMS, INC. k063783 04/27/2007
mini lap pediatric instruments with medusa clamping system MINI LAP TECHNOLOGIES INC. k070352 04/05/2007
hemosil proclot INSTRUMENTATION LABORATORY CO. k070635 03/29/2007
zirblank-ps and zirblank-fs ACUCERA, INC. k070045 03/26/2007
nitrile powder free patient examination gloves TANGSHAN LUXIONG PLASTIC PRODUCTS CO., LTD. k070404 03/26/2007
axsym anti-ccp reagent, standard calibrator and control kits, models 3l91-20, 3l91-01 and 3l91-10 AXIS-SHIELD DIAGNOSTICS, LTD. k063347 03/20/2007
advacoat sinus gel and stent CARBYLAN BIOSURGERY k070496 03/15/2007
sidestream plus RESPIRONICS LTD. k062689 02/16/2007

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