Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Colonic Irrigation System
510(k) Number K860943
Device Name JIMMY JOHN III, RECTAL NOZZLE (MODIFICATION)
Applicant
Colon Therapeutics
2729 Upton Dr.
Port Arthur,  TX  77642
Applicant Contact JIMMY GIROUARD
Correspondent
Colon Therapeutics
2729 Upton Dr.
Port Arthur,  TX  77642
Correspondent Contact JIMMY GIROUARD
Regulation Number876.5220
Classification Product Code
KPL  
Date Received03/12/1986
Decision Date 05/15/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-