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U.S. Department of Health and Human Services

510(K) Premarket Notification

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510(K)
Number
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Decision
Date
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west nile virus igm capture elisa PANBIO LIMITED den030004 07/08/2003
endotoxin activity assay (eaa) device SPECTRAL DIAGNOSTICS, INC. den030002 06/16/2003
spectra-vrm q-switched nd:yag laser system, spectra-vrm TISSUE MEDICAL LASERS, INC. k000317 10/27/2000
vision r/f tilting table VILLA SISTEMI MEDICALI S.P.A. k000412 04/24/2000
aps series dialyzers (wet models), aps series dialysis (dry models) ASAHI MEDICAL CO., LTD. k001250 08/16/2000
disposable powdered nitrile exam glove, white color SHEEN MORE ENT. CO., LTD. k001155 05/23/2000
suni max SATELEC k000049 04/04/2000
acucam concept iv, models a1222b, a1223b, a1221b, a1121b, a1222c, a10402, a10403, a10401 DENTSPLY INTL. k000112 04/13/2000
thermal cautery unit, model 150 GEIGER MEDICAL TECHNOLOGIES, INC. k002341 10/23/2000
ohmeda inovent delivery system OHMEDA MEDICAL den000001 01/11/2000

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