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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
Date
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calex conditioner STEPHEN M. KORAL, D.M.D. k010176 03/27/2001
visualine ii (also known as sunline) amphetamine assay SUN BIOMEDICAL LABORATORIES, INC. k010177 05/17/2001
spermicidal lubricated male latex condom INNOLATEX SDN. BHD k010178 04/27/2001
ebi vuecath spinal endoscopic system EBI, L.P. k010179 02/09/2001
cd horizon spinal system, 4.5 rod for posterior application MEDTRONIC SOFAMOR DANEK, INC. k010181 06/12/2001
vcf personal lubricant APOTHECUS PHARMACEUTICAL CORP. k010182 03/09/2001
global by blastocyst media INTL., INC. k010183 05/02/2001
chess hand surgery system CANICA DESIGN, INC. k010184 06/22/2001
6.0 x 5.7mm dental implant BICON, INC. k010185 12/30/2002
welch allyn impact blood pressure system WELCH ALLYN, INC. k010186 06/08/2001

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