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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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nexwave combo muscle stimulator system Zynex Medical, Inc. k111279 09/20/2011
osteotomes, various types Zinnanti Surgical Instruments, Inc. k891887 04/12/1989
herbert bone screw Zimmer, Inc. k792022 10/26/1979
insall/burstein* ii modular total knee Zimmer, Inc. k872379 10/28/1987
powered wheelchair (nxn20-208, nxn20-211) Zhejiang Nysin Medical Co., Ltd. k241603 11/20/2024
air compression leg massager (mm0520, mm0521, mm0522) Zhangzhou Easepal Medical Science and Technology Co., Ltd. k240373 09/17/2024
xingda nitrile powder free patient examination gloves, blue color Xingda Medical Products Co., Ltd. k152720 03/10/2016
table radiographic fixed X-Ray Systems k855052 02/06/1986
ultrack total knee system Wrightmedicaltechnologyinc k953439 01/30/1996
windsor medical model 52 Windsor Medical, Inc. k832641 10/04/1983

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