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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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glo-spec SOL WEISS MD INC k013817 12/21/2001
biomedics uv colors (ocufilcon d) soft (hydrophilic) contact lens OCULAR SCIENCES PUERTO RICO, INC. k013377 12/20/2001
nicolet electromagnetic navigation system NICOLET BIOMEDICAL k013419 12/20/2001
intramedullary fixation system for the hand HAND INNOVATIONS, INC. k013424 12/20/2001
prosthetic accessories to the iti dental implant system INSTITUT STRAUMANN AG k013798 12/19/2001
acon mop one step opiate test strip, acon mop step opiate test device ACON LABORATORIES, INC. k013380 12/18/2001
advia centaur homocysteine assay BAYER DIAGNOSTICS CORP. k013406 12/18/2001
k-systems culture bag sealer and culture bags type cbs-1 and cb-01 K-SYSTEMS, KIVEX BIOTEC LTD. k013401 12/14/2001
sanyo co2 incubators, models nos. mco-17ac, mco-17aic, mco-20aic,and mc0-175m SANYO NORTH AMERICA CORP. k013703 12/14/2001
modification to:apex medical if-4100 APEX MEDICAL CORP. k013813 12/14/2001

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