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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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johns-allgood irrivac drive-irrigator/aspirator- Dexide, Inc. k854072 11/15/1985
jel bios pure J.F. Jelenko & Co., Inc. k002645 10/19/2000
jel bios 90 (code name rd-2401) J.F. Jelenko & Co., Inc. k001196 05/11/2000
jas calcium (arsenazo) reagent Jas Diagnostics, Inc. k011441 07/09/2001
ise compensation sera Boehringer Mannheim Corp. k870379 02/26/1987
is3 Hiossen, Inc. k180527 05/16/2018
ipl hair removal Dongguan Define Beauty Electronic Technology Co., Ltd. k212318 01/14/2022
iontophoretic drug delivery electrode, iontophoretic electrode (active) Wr Medical Electronics Co. k000574 08/09/2000
ionized calcium and blood ph testcards Ilex Corp. k860639 04/21/1986
intravascular catheter w/doppler transducer NuMED, Inc. k860121 06/02/1986

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