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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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pro m class Saeyang Microtech Co., Ltd. k213897 09/19/2022
injex needle-free injection system; rojex needle-free injection system Rosch AG Medizintechnic k020786 09/25/2002
rocket ipc insertion pack, rocket ipc mini insertion set, rocket ipc dressing pack and bottle set, rocket ipc drainage b Rocket Medical Plc k123033 02/01/2013
modification to integra reagent cassette for hemoglobin a1c Roche Diagnostics Corp. k003120 12/18/2000
accu-chek compact system, accu-chek compact test strips, accu-chek compact compact controls Roche Diagnostics Corp. k004010 04/26/2001
elecsys ca 19-9 calcheck Roche Diagnostics Corp. k051185 07/06/2005
ise indirect na, k, cl for gen.2 Roche Diagnostics Corp. k053165 12/14/2005
protet soap & wash mitt Ritmed, Inc. k830259 05/09/1983
rionet hearing aid hb-69s Rion Acoustic Instruments, Inc. k811529 06/26/1981
pullen plastic-pore plugs Richard'S Medical Equip., Inc. k772066 12/20/1977

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