510(k) K911329

BARD(R) SURECATCH PEDIATRIC URINE COLLECT DEVICE by C.R. Bard, Inc. — Product Code FOC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 28, 1991
Date Received
March 26, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bag, Urine Collection, Newborn
Device Class
Class II
Regulation Number
876.5250
Review Panel
GU
Submission Type