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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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yuwell infrared ear thermometer: yht101, yht200 Jiangsu Yuyue Medical Equipment& Supply Co., Ltd. k203583 05/20/2021
latex examination gloves Jiahn Chiaur Enterprise Co., Ltd. k894195 07/28/1989
acrylic reading and polycarbonate lenses sunglasses Jane Fui Optical Co., Ltd. k962279 08/26/1996
model 704 Ivy Biomedical Systems, Inc. k912139 03/25/1992
harmony line kf Ivoclar North America, Inc. k951297 04/18/1995
irrisept wound debridement and cleansing system Irrimax Corporation k202222 12/14/2020
intuitive surgical onsite for da vinci surgical systems Intuitive Surgical, Inc. k121921 10/25/2012
right atrial catheter catalog no. rac - xxx series Intracath, Inc. k860699 04/02/1986
jai Intl. Trade Management Co. k951513 05/25/1995
integra (r) jarit (r) kerrison rongeurs, integra (r) ruggles (tm)-redmons (tm) kerrison rongeurs, integra (r) miltex (r) kerrison rongeurs, integra (r) meisterhand (r) kerrison rongeurs Integra Lifesciences Corp. k150428 04/16/2015

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