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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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ksea monopolar vaporization electrodes KARL STORZ ENDOSCOPY-AMERICA, INC. k001740 08/22/2000
radionics rf disc catheter electrode system RADIONICS, INC. k001741 10/23/2000
resusci inflate-a-shield cpr barrier LAERDAL MEDICAL CORP. k001742 10/06/2000
ultima smartbelt, model 0560 BRAEBON MEDICAL CORP. k001743 08/25/2000
olympus endoscopic ligation device OLYMPUS AMERICA, INC. k001744 02/27/2001
modification to provident hip system STELKAST COMPANY k001745 07/27/2000
lightsheer pulsed diode array laser system (family of products) COHERENT STAR k001746 07/19/2000
lactosorb meniscal screw BIOMET MANUFACTURING, INC. k002020 08/25/2000
hemostatix thermal scalpel system - #12 blade GYRUS ENT L.L.C. k002021 08/24/2000
medmira rapid h. pylori antibody test, model 10714 MEDMIRA LABORATORIES, INC. k002023 11/13/2000

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