510(k) K860943

JIMMY JOHN III, RECTAL NOZZLE (MODIFICATION) by Colon Therapeutics — Product Code KPL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 15, 1986
Date Received
March 12, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Colonic Irrigation System
Device Class
Class II
Regulation Number
876.5220
Review Panel
GU
Submission Type