01608nam 2200373Ia 450 991069883580332120090522142308.0(CKB)5470000002397509(OCoLC)341605154(EXLCZ)99547000000239750920090522d2004 ua 0enguran|||||||||txtrdacontentcrdamediacrrdacarrierFDA and industry actions on premarket notification (510(k)) submissions, effect on FDA review clock and performance assessment[electronic resource]Rockville, MD :U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health :Center for Biologics Evaluation and Research,[2004]14 pages digital, PDF fileTitle from PDF title page (viewed on May 22, 2009)."Document issued on: May 21, 2004".FDA and industry actions on premarket notification User chargesUnited StatesMedical instruments and apparatusUnited StatesEvaluationUser chargesMedical instruments and apparatusEvaluation.Center for Devices and Radiological Health (U.S.)Center for Biologics Evaluation and Research (U.S.)GPOGPOBOOK9910698835803321FDA and industry actions on premarket notification (510(k)) submissions, effect on FDA review clock and performance assessment3174882UNINA