FOC — Bag, Urine Collection, Newborn Class II

FDA Device Classification

Classification Details

Product Code
FOC
Device Class
Class II
Regulation Number
876.5250
Submission Type
Review Panel
GU
Medical Specialty
Gastroenterology, Urology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K950176hollisterPREMIE U-BAG URINE SPECIMEN COLLECTORFebruary 7, 1995
K943752rimeco productsRIMECO MIDSTREAM URINE COLLECTORNovember 1, 1994
K911329c.r. bardBARD(R) SURECATCH PEDIATRIC URINE COLLECT DEVICEMay 28, 1991
K771368cavitronPORTABLE INFANT VENTILATORAugust 4, 1977