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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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510(K)
Number
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Decision
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ac powered thermal cautery unit STARION INSTRUMENTS k000893 06/14/2000
standard imaging hdr 1000 plus ion chamber; standard imaging ivb 1000 ion chamber STANDARD IMAGING, INC. k001825 08/02/2000
stackhouse lens hood, model sa-700/f STACKHOUSE, INC. k000605 08/17/2000
biogel neotech ii powder-free neoprene surgeon's glove SSL AMERICAS, INC. (REGENT MEDICAL) k000421 08/14/2000
k-centrum anterior spinal fixation system SPINEOLOGY, INC. k002371 09/15/2000
ascend spinal fixation system SPINAL INNOVATIONS, LLC. k002069 10/05/2000
speedlink transverse connector SPINAL CONCEPTS, INC. k002082 10/06/2000
bilichek non-invasive bilirubin analyzer SPECTRX, INC. k994438 02/04/2000
specialty 42 (hefilcon a) hydrophilic contact lens for daily wear, specialty t-42 toric (hefilcon a) hydrophilic contact SPECIALTY ULTRAVISION, INC. k000376 03/21/2000
s57d digital operating room camera SOPRO k000422 03/31/2000

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