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 K152834
Device Name Colonplus Colonkit small, Colonplus Colonkit large, Colonplus Colonkit with Stop Collar 6, Colonplus Colonkit with Stop Collar 10
Applicant
Colonplus Equipments & Speculums, S.L.
C/Portuetxe 13, 1 C 20018
San Sebastian (Guipuzcoa),  ES
Applicant Contact Jorge Echevarria
Correspondent
Business Excellence Consulting, Inc.
City View Plaza Suite #802/ #48 Rd. 165 Km 1.2
Guaynabo,  PR 00968
Correspondent Contact Solmarie Velez Rivera
Regulation Number876.5220
Classification Product Code
KPL  
Date Received09/29/2015
Decision Date 08/10/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-