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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
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electrostatic hydrophobic breathing filter SIMS PORTEX, INC. k002201 02/05/2001
electrosurgical electrode family NOVASYS MEDICAL, INC. k001151 06/27/2000
electrosurgical electrode family, model 20-2 needle balloon catheter, model 40-4 needle balloon catheter, model 60-6 nee NOVASYS MEDICAL, INC. k001150 06/29/2000
eliachar laryngeal foam stent, model ell-1 E. BENSON HOOD LAB, INC. k000154 03/29/2000
ems jumper ii dual channel neuromuscular stimulator system, model e-188 138 MEDICAL SUPPLIES, INC. k000741 10/24/2001
encore microptic powder free latex surgical gloves, model 87 ANSELL HEALTHCARE PRODUCTS, INC. k003769 12/22/2000
encore powder-free latex surgical gloves, orthopaedic with protein content labeling claim (50 micrograms or less) ANSELL HEALTHCARE PRODUCTS, INC. k003771 01/16/2001
endoscopic tube shaft instruments for monoplar coagulation ANTYLLOS MEDIZINTECHNIK GMBH k010192 04/02/2001
enhanced compensating filter COMPUTERIZED MEDICAL SYSTEMS, INC. k000137 04/17/2000
enhanced polyethylene knee prostheses HOWMEDICA OSTEONICS CORP. k001147 02/15/2001

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