FDA 510(k) 实质等同认定·· 2026-09-01
510(k) 实质等同认定：PRIMED Chemotherapy Drug Tested Gowns (PM4-99450: PRIMED Chemotherapy Drug Tested Isolation Gown, Purple, AAMI Level 2; PM4-99460: PRIMED Chemotherapy Drug Tested Isolation Gown, Blue, AAMI Level 3)（K261811）
来源：FDA 510(k) 实质等同认定 · accessdata.fda.gov