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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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quantimetrix total creatine kinase control Quantimetrix Medical Industries k874302 02/02/1988
opti-fix collared femoral components Richards Medical Co., Inc. k874868 01/26/1988
rigid-lens case Sola Ophthalmics k874657 12/08/1987
insall/burstein* ii modular total knee Zimmer, Inc. k872379 10/28/1987
easy-test emit procainamide (proc) #16648 Em Diagnostic Systems, Inc. k873350 09/29/1987
model 20-c w/ar-10a/u attach. for arthro. surgery Directed Energy, Inc. k872711 09/28/1987
denture cleansing tablet Pennex Products Co., Inc. k871785 09/11/1987
porocoat mark ii total elbow Depuy, Inc. k872084 06/25/1987
denti-tray(tm) Advanced Medical, Inc. k871493 06/24/1987
sigma's calcium procedure no. 587 Sigma Diagnostics, Inc. k871152 06/12/1987

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