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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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insight image guided surgical system SURGICAL INSIGHTS, INC. k001642 09/12/2000
pva foam embolization particles SURGICA CORP. k001678 01/25/2001
sterile powdered latex surgeon gloves SUPERMAX GLOVE MANUFACTURING SDN BHD k010198 02/23/2001
visualine ii (also known as sunline) amphetamine assay SUN BIOMEDICAL LABORATORIES, INC. k010177 05/17/2001
allofit acetabular system SULZER ORTHOPEDICS, INC. k003758 03/07/2001
stryker navigation system - ent module STRYKER CORP. k002732 10/02/2000
simplicity disposable pen needle STERLING MEDIVATIONS, INC. k002180 10/13/2000
simplicity infuser infusion set STERLING MEDIVATIONS, INC. k010647 04/13/2001
steritec autoclave tapes, model ci122 & ci1234 STERITEC PRODUCTS, INC. k001649 06/23/2000
calex conditioner STEPHEN M. KORAL, D.M.D. k010176 03/27/2001

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