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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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integra oxygen concentrators model 6400-om Sequal Technologies, Inc. k003472 06/04/2001
iscreen vision screener Iscreen, LLC k010315 06/01/2001
synthes synex spacer system Synthes k003836 05/29/2001
modification to instant-view methamphetamine (meth 1000) urine test (dip strip) Alfa Scientific Designs, Inc. k003845 05/29/2001
modification to instant-view methamphetyamine (meth1000) urine test (cassette) Alfa Scientific Designs, Inc. k003847 05/29/2001
instant-view phencyclidine (pcp) urine dip strip test Alfa Scientific Designs, Inc. k010045 05/29/2001
instant-view phencyclidine (pcp) urine cassette test Alfa Scientific Designs, Inc. k010047 05/29/2001
k-assay d-dimer with calibrator set and calibrator diluent Kamiya Biomedical Co. k002948 05/18/2001
radcalc, model v.4.0 Lifeline Software, Inc. k010464 05/17/2001
horizons international varices injection needles Horizons Intl. Corp. k010448 05/16/2001

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