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U.S. Department of Health and Human Services

510(K) Premarket Notification
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Applicant
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510(K)
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Decision
Date
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modification to rapid drug screen 9-panel American Bio Medica Corp. k002447 11/16/2000
modification to isobar spinal system Encore Orthopedics, Inc. k000020 02/03/2000
modification to isobar spinal system Encore Orthopedics, Inc. k002959 10/16/2000
modification to instant-view methamphetyamine (meth1000) urine test (cassette) Alfa Scientific Designs, Inc. k003847 05/29/2001
modification to instant-view methamphetamine (meth 1000) urine test (dip strip) Alfa Scientific Designs, Inc. k003845 05/29/2001
modification to exactech acumatch integrated hip system, m-series high off-set neck segment, m-series low off-set neck s Exactech, Inc. k010120 02/09/2001
modification to datascope profile 8fr. iab, 34cc; modification to datascope profile 8fr. iab, 40cc Datascope Corp. k002949 10/20/2000
modification to chad therapeutics oxymatic model 401 Chad Therapeutics, Inc. k003455 12/06/2000
modification to centaur spinal system Howmedica Osteonics Corp. k001844 07/19/2000
modification to cavermap surgical aid Uromed Corp. k010098 02/01/2001

*   The maximum 500 records meeting your search criteria returned. Please narrow your search.
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