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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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insall/burstein* ii modular total knee Zimmer, Inc. k872379 10/28/1987
model 20-c w/ar-10a/u attach. for arthro. surgery Directed Energy, Inc. k872711 09/28/1987
starkey model p1 module Starkey Laboratories, Inc. k873031 02/08/1988
easy-test emit procainamide (proc) #16648 Em Diagnostic Systems, Inc. k873350 09/29/1987
musculoskeletal evaluation rehabilitation/conditio Universal Gym Equipment, Inc. k873659 04/21/1988
guide wire introducer Target Therapeutics k873972 04/01/1988
quantimetrix total creatine kinase control Quantimetrix Medical Industries k874302 02/02/1988
rigid-lens case Sola Ophthalmics k874657 12/08/1987
opti-fix collared femoral components Richards Medical Co., Inc. k874868 01/26/1988
emit 700 cannabinoid 100 ng calibrator & control Syva Co. k875135 04/05/1988

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