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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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pacendo sodium hyprochlorite PAC-DENT INTERNATIONAL, INC. k151852 11/10/2015
latex examination gloves-pre-powdered-sterile P.T. MAJA AGUNG LATEXINDO k994255 02/07/2000
start family of manual wheelchairs (basic, plus, multi and hemi) OTTO BOCK HEALTH CARE, LP k052681 10/06/2005
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
vitoss scaffold synthetic cancellous bone void filler ORTHOVITA CO. k994337 12/14/2000
5.0mm spinal screws ORTHOTEC, L.L.C. k994288 04/10/2000
orthopro steinman pins and kirschner wires ORTHOPRO LLC k070555 07/13/2007
ankle trauma system ORTHOPRO LLC k122936 02/28/2013
ortho development balanced knee system ORTHO DEVELOPMENT CORP. k994370 03/24/2000
bact/alert sv ORGANON TEKNIKA CORP. k994343 02/10/2000

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