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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
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hoffmann lrf (limb reconstruction frame) system STRYKER CORP. k113327 03/29/2012
human heart valve, cryovalve sg CRYOLIFE, INC. k033484 02/07/2008
i-root S-DENTI CO., LTD. k100450 11/18/2010
ilt support catheter .014, model c114lw1; ilt support catheter advancing mechanism, model a11am1 INTRALUMINAL THERAPEUTICS, INC. k012169 08/30/2001
ilt torquer, model 114tr1 INTRALUMINAL THERAPEUTICS, INC. k021243 07/11/2002
imagegrid CANDELIS, INC. k080333 02/22/2008
immix thin film, models: pss-004-s, pss-004-sp, pss-004-m, pss-004-mp, pss-004-l, pss-004-lp OSTEOBIOLOGICS, INC. k024199 03/14/2003
immulite 2000 pap, models l2kpa2, l2kpa6 DIAGNOSTIC PRODUCTS CORP. k000257 02/23/2000
immunoassay plus control, levels 1, 2, and 3 CONSOLIDATED TECHNOLOGY k020237 03/19/2002
inqwire diagnostic guide wire MERIT MEDICAL SYSTEMS, INC. k002289 10/04/2000

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