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 Accessories, Germicide, Cleaning, For Endoscopes
510(k) Number K123768
Device Name RELIANCE ADVANCE ENDOSCOPE PROCESSING SYSTEM
Applicant
STERIS Corporation
5960 Heisley Road
Mentor,  OH  44060
Applicant Contact MARCIA L BENEDICT
Correspondent
STERIS Corporation
5960 Heisley Road
Mentor,  OH  44060
Correspondent Contact MARCIA L BENEDICT
Regulation Number876.1500
Classification Product Code
NZA  
Date Received12/07/2012
Decision Date 07/26/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-