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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
Sort by PMA Number [0-9]
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510(K)
Number
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Decision
Date
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osteotomy truss system (ots) 4Web, Inc. k172294 02/22/2018
a-bec 18 A-Bec Mobility, Inc. k865002 02/06/1987
w&h micro motor e25 (without light) A-Dec, Inc. k944712 08/25/1995
audit(r) microlq(tm) serum protein control Aalto Scientific, Ltd. k112705 01/24/2012
ticarcillin/clavulanic acid 2 Ab Biodisk k951879 07/07/1995
cybrex lidocaine Abbott Laboratories k802131 10/31/1980
flexiflo low-profile balloon gastrostomy tube Abbott Laboratories k962554 11/07/1997
uric acid reagent Ac Biochemical Laboratories, Inc. k822913 12/20/1982
accu-stat home drug test cup for maijuanna (thc), cocaine (coc), amphetamine (amp), methamphetamine (mamp), ecstasy Accu-Stat Diagnostics, Inc. k041221 07/13/2004
cpap infant nasal cannulae set Ackrad Laboratories k823936 01/28/1983

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