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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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smith & nephew operative hysteroscope, model 7209208; smith & nephew continuous flow sheath, model 8105224 SMITH & NEPHEW, INC. k013870 01/17/2002
modification to smith & nephew twinfix ti quick t SMITH & NEPHEW, INC. k023021 10/04/2002
gelclair concentrated oral gel SINCLAIR PHARMACEUTICALS, LTD. k013056 12/21/2001
wallace oocyte retrieval set-16g, model meons1633; wallace oocyte retrieval set-17g, model meons1733 SIMS PORTEX LTD. k000628 03/13/2000
sigma diagnostics infinity glucose reagent, models 17-25, 17-100p, 17-500p, 17-2000p, 18-20, 18-100p SIGMA DIAGNOSTICS, INC. k001403 08/10/2000
omnia x/xs ultrasound system SIEMENS MEDICAL SYSTEMS, INC. k020353 02/13/2002
elegra millennium enhanced diagnostic ultrasound system SIEMENS MEDICAL SOLUTIONS USA, INC. k001400 08/01/2000
nitrile patient examination glove, powdered, non-sterile, (multiple colors) SIAM SEMPERMED CORP. LTD. k002391 12/04/2000
smart shield non-sterile powder-free peppermint scented green latex examination gloves SHIELD GLOVES MANUFACTURER (M) SDN BHD k000156 02/18/2000
cashmere non-sterile, powder free nitrile examination gloves (white) SEAL POLYMER INDUSTRIES BHD. k020868 04/22/2002

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