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U.S. Department of Health and Human Services

510(K) Premarket Notification

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Device Name
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Applicant
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510(K)
Number
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Decision
Date
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transfer companion hr 3000 manual wheelchair FOREVER YOUNG ENT. CO., LTD. k022699 09/13/2002
traction units BIOMET, INC. k780228 02/23/1978
torx or type micro motor handpiece KELLEHER CORP. k822008 08/12/1982
tizian blank, tizian zirconium reinforced composite blank, tizian color blank, tizian blank occlusal, tizian blank trans SCHUTZ-DENTAL GMBH k133268 02/12/2015
tisuthes e-ptfe surgical patch Shanghai Suokang Medical Implants Co., Ltd. k201153 06/13/2023
timeter produced chemetron (ncg) air TIMETER INSTRUMENT CORP. k811550 06/18/1981
thermal well temperature sensor MON-A-THERM, INC. k821504 06/23/1982
the infrared forehead thermometer, model fs-300&301 HUBDIC CO., LTD k101912 11/10/2010
the aio solution 3.0 Orfit Industries NV k202068 08/14/2020
thayer-martin medium ISLE MEDIA AND STERILE PRODUCTS, INC. k791483 08/22/1979

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