FOC · Class II · 21 CFR 876.5250

FDA Product Code FOC: Bag, Urine Collection, Newborn

Leading manufacturers include Cavitron Corp., C.R. Bard, Inc. and Hollister, Inc..

4
Total
4
Cleared
46d
Avg days
1977
Since

FDA 510(k) Cleared Bag, Urine Collection, Newborn Devices (Product Code FOC)

4 devices
1–4 of 4
Cleared Feb 07, 1995
PREMIE U-BAG URINE SPECIMEN COLLECTOR
K950176
Hollister, Inc.
Gastroenterology & Urology · 21d
Cleared May 28, 1991
BARD(R) SURECATCH PEDIATRIC URINE COLLECT DEVICE
K911329
C.R. Bard, Inc.
Gastroenterology & Urology · 63d
Cleared Aug 04, 1977
PORTABLE INFANT VENTILATOR
K771368
Cavitron Corp.
Gastroenterology & Urology · 10d

About Product Code FOC - Regulatory Context