510(k) K924406

CONVEEN(R) LEG BAG(500 ML) by Coloplast A/S — Product Code FAQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 30, 1992
Date Received
August 25, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bag, Urine Collection, Leg, For External Use, Sterile
Device Class
Class I
Regulation Number
876.5250
Review Panel
GU
Submission Type