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 system, peritoneal, automatic delivery
510(k) Number K910173
Device Name SELECTRA AND TUBING SETS
Applicant
MEDIONICS INTERNATIONAL LTD.
114 ANDERSON AVENUE
MARKHLAM, ONTARIO,
CANADA L6E 1A5,  CA
Applicant Contact MAHESH AGARWAL
Correspondent
MEDIONICS INTERNATIONAL LTD.
114 ANDERSON AVENUE
MARKHLAM, ONTARIO,
CANADA L6E 1A5,  CA
Correspondent Contact MAHESH AGARWAL
Regulation Number876.5630
Classification Product Code
FKX  
Date Received01/15/1991
Decision Date 01/13/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-