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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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novabone-bioglass bone graft particulate U.S. BIOMATERIALS CORP. k000149 02/07/2000
cardiosentry event monitor, model 8470-01 TZ MEDICAL, INC. k001634 12/21/2000
aerotrach plus valved holding chamber (vhc) TRUDELL MEDICAL INT'L k001137 07/05/2000
omnipulse holmium laser system, omnipulse-max holmium laser system, model 1210, 1210-vhp, 1500-a TRIMEDYNE, INC. k001676 11/02/2000
transamerica digital ems TRANSAMERICA MEDICAL SYSTEMS k010665 04/27/2001
tornier total elbow prosthesis TORNIER k000003 10/02/2000
powdered synthetic vinyl patient exam glove TONG RUHN MEDICAL PRODUCTS CO., LTD. k010663 03/30/2001
o-ring prosthetic attachment TITAN IMPLANTS k001638 03/04/2002
modification to tissuelink bipolar forceps TISSUELINK MEDICAL, INC. k010661 05/03/2001
modification to tissuelink monopolar floating ball TISSUELINK MEDICAL, INC. k010662 04/27/2001

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