510(k) K905016

PEDIATRIC AND INFANT CATH KITS by Davol, Inc. — Product Code FFH

Clearance Details

Decision
SESD (Substantially Equivalent (with conditions))
Decision Date
December 20, 1990
Date Received
November 7, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Collector, Urine, Pediatric, For Indwelling Catheter
Device Class
Class II
Regulation Number
876.5250
Review Panel
GU
Submission Type