510(k) K863830

CONSEAL(TM) COLOSTOMY CONTINENCE SYSTEM by Coloplast A/S — Product Code EZQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 16, 1986
Date Received
September 30, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pouch, Colostomy
Device Class
Class I
Regulation Number
876.5900
Review Panel
GU
Submission Type