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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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picis chart+ Picis k950536 05/17/1995
fx-2 nms (2channel table model) Fx-2 k945509 05/02/1995
themo-flo system 3 laparoscopic/hysteroscopic system Sanese Medical Corp. k941507 03/06/1995
blood kit, sexual assault kit Lynn Peavey Co. k945245 02/01/1995
big phil Biomedical Waste Systems, Inc. k946027 01/26/1995
silkon titanium cable system American Medical Electronics, Inc. k942300 01/09/1995
an-10s andersen tube with stylet H.W. Andersen Products, Inc. k935688 12/30/1994
electrosurgical cutting and coagulating device and accessories Megadyne Medical Products, Inc. k943055 12/21/1994
osteonics series 7000 basic femoral components Osteonics Corp. k941128 12/08/1994
r2 pads, r2 cath pads, r2 pace pads, r2 dispersive pad R2 Medical Systems k935371 12/02/1994

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