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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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510(K)
Number
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Decision
Date
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the titanium fixation system Biomedics k943071 01/06/1995
retic control-m hematology control/multiple R&D Systems, Inc. k943335 12/12/1994
lasersonics surgical laser systems and accessories Heraeus Surgical, Inc. k943716 03/14/1995
forceps, surgical gynecological Owens Precision Systems, Inc. k944055 09/20/1994
stryker steri-shield surgical apparel Stryker Corp. k944393 08/28/1995
w&h micro motor e25 (without light) A-Dec, Inc. k944712 08/25/1995
ebice Electro-Biology, Inc. k945067 02/09/1995
rosebud dissector Lorrex Health Products k945332 12/05/1994
cobas(r)-fp reagents for gentamicin and cobas(r)-fp gentamicin calibrators Roche Diagnostic Systems, Inc. k945523 03/09/1995
dermassist(tm) hydrogel saturated gauze dressing Wilshire Medical Products k946030 02/27/1995

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