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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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Decision
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shaver ablator LINVATEC CORP. k002088 03/06/2001
series 7700 mobile c-arm, compact 7700 mobile c-arm, compact 7700 plus mobile c-arm GE DEC MEDICAL SYSTEMS k000221 04/11/2000
sensititre susceptibility plates-additional antimicrobics TREK DIAGNOSTIC SYSTEMS, INC. k003868 02/27/2001
sensidyne oxygen analyzer & sensidyne oxygen monitor SENSIDYNE, INC. k000700 08/31/2000
secca tubular electrode device, model a4000 CONWAY STUART MEDICAL, INC. k000170 02/14/2000
sealouette fibrin sealant extended droplet applicator, model te-1 BIOSURGICAL CORP. k000048 01/31/2000
screeners methamphetamine test, drugscreen dip methamphetamine test DRUG DETECTION DEVICES, LTD. k000452 04/24/2000
screeners benzodiazepine (bzd) test, drug screen dip benzodiazepine (bzd) test DRUG DETECTION DEVICES, LTD. k000449 04/07/2000
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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