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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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dermassist(tm) hydrogel saturated gauze dressing Wilshire Medical Products k946030 02/27/1995
ebice Electro-Biology, Inc. k945067 02/09/1995
mini laparoscopy for general surgery Olympus America, Inc. k950278 02/01/1995
model 2730 clinical refractometer Vee Gee Scientific, Inc. k941906 01/17/1995
the titanium fixation system Biomedics k943071 01/06/1995
retic control-m hematology control/multiple R&D Systems, Inc. k943335 12/12/1994
powder-free latex examination gloves Pacificlink Exp.Industries Private , Ltd. k942856 12/07/1994
rosebud dissector Lorrex Health Products k945332 12/05/1994
forceps, surgical gynecological Owens Precision Systems, Inc. k944055 09/20/1994
culture-pak collection and transport system Medical Packaging Corp. k932337 08/16/1994

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