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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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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
modification to nc-stat Neurometrix, Inc. k000565 06/27/2000
electrosurgical electrode family Novasys Medical, Inc. k001151 06/27/2000
monarch ii iol delivery system Alcon Research, Ltd. k001157 06/27/2000
audio technologies s:r.1 Audio Technologies S.R.L. k001142 06/23/2000
temporary gingival cuff and impression post and implant analog Sulzer Calcitek, Inc. k001786 06/21/2000
hyfrecator 2000 reusable hand-switching accessory handpiece/foot-switching accessory handpiece, hyfrecator plus reusabl Conmedcorp k001159 06/07/2000
ultrapen reusable pencil, model 130350 through 130353, reusable accessory electrode kit (for use with ultrapen pencil), Conmedcorp k001161 06/07/2000
merogel otologic pack Xomed, Inc. k001148 06/03/2000
disposable powdered nitrile exam glove, white color Sheen More Ent. Co., Ltd. k001155 05/23/2000

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