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U.S. Department of Health and Human Services

510(K) Premarket Notification

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510(K)
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omnipulse holmium laser system, model 1210; omnipulse max holmium laser system, model 1210-vhp and 1500-a TRIMEDYNE, INC. k002308 12/20/2000
lithium regent model tr66056 / lithium standard tr66901 TRACE AMERICA, INC. k003583 01/17/2001
tornier total elbow prosthesis TORNIER k000003 10/02/2000
top quality chlorinated-powderfree examination gloves TOP QUALITY MFG., INC. k000050 07/27/2000
skingard polycoat glove TOP QUALITY MFG., INC. k004018 05/11/2001
tissuelink monopolar floating ball' TISSUELINK MEDICAL, INC. k002680 11/13/2000
ultra care 2 latex examination gloves made from allotex (enzyme treated) natural rubber latex with a protein content lab TILLOTSON HEALTHCARE CORP. k002718 05/01/2001
formula one powdered latex examination glove, with protein content labeling claim 200 micrograms or less and made from a TILLOTSON HEALTHCARE CORP. k002719 01/26/2001
formula one sterile latex examination gloves with protein content labeling claim (200 micrograms or less) made from allo TILLOTSON HEALTHCARE CORP. k002720 11/09/2000
splittable sheath introducer kit THOMAS MEDICAL PRODUCTS, INC. k004025 07/19/2001

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