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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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510(K)
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bone-lok bioabsorbable compression anchor with titanium fixture , model bmcd-35-3040, mbcd-35-4050 TRIAGE MEDICAL INC k014243 03/26/2002
nebulizer set-2c7105 TRAVENOL LABORATORIES, S.A. k772222 12/22/1977
xo cath microcatheter (e20-090-s, e20-110-s, e20-130-s, e20-150-s, e20-175-s, e20-220-s, e20-090-b, e20-110-b, e20-130-b, e20-150-b, e20-175-b, e20-220-b, e26-090-s, e26-110-s, e26-130-s, e26-150-s, e26-175-s, e26-220-s, e26-090-b, e26-110-b, e26-130-b, e26-150-b, e26-175-b, e26-220-b,) Transit Scientific, LLC k231821 11/29/2023
speech audiometer ra 226 TRACOR INSTRUMENTS, INC. k780749 05/16/1978
tono-pen tonometer tip cover TRA & ACCESSORIES k033146 11/23/2004
st aia-pack 25-oh vitamin d, st aia-pack 25-oh vitamin d calibrator set, aia-pack 25-oh vitamin d control set, and st aia-pack 25-oh vitamin d pretreatment set TOSOH BIOSCIENCE, INC. k150270 10/26/2015
aequalis shoulder fracture system TORNIER k032679 12/15/2003
medisign mm1000 bt blood glucose monitoring system, medisign mm1100 bt blood glucose monitoring system, medisign mm1200 bt blood glucose monitoring system, smart diabetes bluetooth blood glucose monitoring system, medisign mm 1000 bt multi blood glucose monitoring system, medisign mm 1100 bt multi TIANJIN EMPECS MEDICAL DEVICE CO., LTD. k152534 03/21/2017
multi-unit, multi-purpose device THE SCOTT & FETZER CO. k813638 05/07/1982
stockinette, sterile two ply w/pull tabs THE OWENBY CO. k801532 07/28/1980

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