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U.S. Department of Health and Human Services

510(K) Premarket Notification

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510(K)
Number
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Decision
Date
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primaflow DMG USA, INC. k002086 08/17/2000
bestex powder-free latex exam gloves with labeling claim. (50 micrograms or less) QINGDAO BESTEX RUBBER & PLASTIC PRODUCTS CO., LTD k002087 09/13/2000
shaver ablator LINVATEC CORP. k002088 03/06/2001
rosetta-lt/rosetta-rx GENERAL DEVICES k002089 11/21/2000
atrium lite mesh ATRIUM MEDICAL CORP. k002093 07/24/2000
bard memotherm covered esophageal stent, model multiple C.R. BARD, INC. k002094 10/06/2000
snap model 6 SNAP LABORATORIES, L.L.C. k002095 03/02/2001
tampax satin tampons, closed end flushable applicator; tampax tampons, open end flushable applicator PROCTER & GAMBLE CO. k002096 09/08/2000
salumedica nerve cuff SALUMEDICA, L.L.C. k002098 11/24/2000
s38 (polymacon) spherical, aspherical, toric and multifocal soft contact lens for daily wear(clear and tinted, fully- BESCON CO., LTD. k002099 07/09/2001

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