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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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k-pack ii needle- 27g & 30g thin wall TERUMO EUROPE N.V. k110850 06/09/2011
water pik traveler, model 79 TELEDYNE, INC. k800448 03/05/1980
pulse generator, model 171 TELECTRONICS, INC. k782161 07/24/1979
argostat TECNOMED, INC. k811195 06/09/1981
limb holder, tecnol reminder TECNOL NEW JERSEY WOUND CARE, INC. k760309 08/09/1976
disposable hypodermic emg needle electrode technomed europe version and private labeled TECHNOMED EUROPE k062437 02/16/2007
tanit home suntanning unit TANIT, INC. k800950 06/04/1980
dynamic tibase Talladium España, SL k232151 10/17/2023
phot-x iis model 505 TAKARA BELMONT CORPORATION k141293 09/03/2014
emit qst quinidine assay SYVA CO. k831355 06/02/1983

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