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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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olympus guide sheath, model xbo1-836-13 Olympus Medical Systems Corporation k060243 06/23/2006
mini laparoscopy for general surgery Olympus America, Inc. k950278 02/01/1995
modified olsen 755/756 switchpens Olsen Electrosurgical, Inc. k884174 10/24/1988
angioplus-s Oec-Diasonics, Inc. k843972 01/03/1985
loyon Oculus Innovative Sciences k162217 03/23/2017
tigr matrix surgical mesh Novus Scientific AB k163005 07/27/2017
novalens/novawet sphjerical & perception & vanguard multifocal &/or bifocal (rosifocon a) rigid gas permeable contact lr Novavision, Inc. k955900 03/25/1996
nova 12 analyzer, modification Nova Biomedical Corp. k924743 11/06/1992
nova chemistry performance check solution Nova Biomedical Corp. k955260 02/02/1996
sterile instrument drape North American Sterilization & Packaging Co. k902763 09/20/1990

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