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U.S. Department of Health and Human Services

510(K) Premarket Notification
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510(K)
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xltek evoked potential headbox, model ep-4-rp (proposed) Excel Tech. , Ltd. k010090 03/26/2001
eeg with video, model ex-nw Excel Tech. , Ltd. k010091 02/01/2001
xltek evoked potential headbox, model real patient ep-8-rp (proposed) Excel Tech. , Ltd. k010092 04/02/2001
equinoxe uhmwpe 12* posterior augment pegged glenoid, small / medium / large / extra-large, left / right Exactech, Inc. k111379 06/08/2011
vicryl polyglactin 910 sterile synthetic absorbable surgical suture, pds ii polydioxanone sterile synthetic absorbable surgical suture, pds plus antibacterial polydioxanone sterile synthetic absorbable surgical suture ETHICON, Inc. k183183 06/27/2019
mammotome hand held probe, model mhh8 Ethicon Endo-Surgery, Inc. k003297 01/18/2001
!nsure fecal occult blood test Enterix, Inc. k002457 01/12/2001
modification to isobar spinal system Encore Orthopedics, Inc. k000020 02/03/2000
suction irrigation electrodes and adapters Encision, Inc. k100711 06/09/2010
aem disposable suction irrigation electrodes Encision, Inc. k131949 08/26/2013

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