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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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paxial Biophysic Medical, Inc. k853116 10/31/1985
nail splint Inro Medical Designs, Inc. k850803 10/16/1985
sonolayer-v, ssa-90a Toshiba Medical Systems k851036 09/17/1985
posicam tm(model 3.2,4.3,6.5) Position Corp. k852239 09/03/1985
i.a.s.s., iv set w/air vent & i.a.p.s. w/o airvent Migada, Ltd. k853385 08/23/1985
general diagnostics coag-a-mate xc Warner-Lambert Co. k852843 08/13/1985
airlife electronic incentive spirometer American Pharmaseal Div. Ahsc k851334 08/06/1985
varices injector Wilson-Cook Medical, Inc. k851952 07/26/1985
pennine nelaton catheters sizes 5,6,8,10,12,14,16, Pennine Medical , Ltd. k844876 06/05/1985
omnimed clamp Omni Intl., Inc. k851654 05/31/1985

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