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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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optyse ophthalmoscope Ophthalmos , Ltd. k061278 05/16/2006
opus hc482 direct nasal mask Fisher &Paykel Healthcare , Ltd. k063036 12/22/2006
oral/enteral syringes Philips Children'S Medical Ventures k100099 06/14/2010
ortho aligner system Ortho Lab Services, LLC k212496 11/04/2021
ortholux visible light curing unit Unitek Corp. k880392 04/07/1988
orthovita piston syringe or imbibe bone marrow aspiration syringe Orthovita, Inc. k011087 09/19/2001
osteonics cement restrictor Osteonics Corp. k900462 03/06/1990
osteotomes, various types Zinnanti Surgical Instruments, Inc. k891887 04/12/1989
osteotomy truss system (ots) 4Web, Inc. k172294 02/22/2018
overjet periapical radiolucency assist Overjet, Inc. k231678 09/21/2023

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