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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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disposable medical surgical masks Tianjin Teda Jinshan Easy Packing Manufacture Co., Ltd. k202323 02/02/2021
lancing device (hh-xv-t) Tianjin Huahong Technology Co., Ltd. k253706 12/09/2025
the monitor electronic bed alarm system The Monitor Corp. k901330 08/30/1990
microoptical's critical data viewers, models md-3 and md-6 The Microoptical Corporation k040244 03/24/2004
lifestyle mv2 (tm) toric (polymacon) soft (hydrophilic) multifocal contact lens for daily wear (clear or tinted) The Lifestyle Co., Inc. k000529 03/21/2000
sterilizing forceps, 3-pronge, 11+ss 410 or 420 The Huxley Instrument Corp. k852722 07/15/1985
surshield winged infusion set Terumo Medical Corp. k010103 03/15/2001
distal clavicular fragment immobilization plate left, model 1810-116_126-03 (05,07) right 1811-116_126-03 (05,07) Terray Corp. k063275 07/27/2007
tdr-4s monaural hearing aid/wireless fm receiver Telex Communications, Inc. k915384 01/17/1992
rusch endotracheal tubes (reinforced); rusch endotracheal tubes (safety clear); rusch endotracheal tubes (safety clear pediatric) Teleflex Incorporated k241451 02/11/2025

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