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 Indicator, Physical/Chemical Sterilization Process
510(k) Number K162758
Device Name VERIFY SixCess Steam Indicators, VERIFY SixCess Flash Indicators, VERIFY Bowie Dick Test Pack, VERIFY SixCess Challenge Pack, VERIFY SixCess FP Challenge Pack
Applicant
STERIS Corporation
5960 Heisley Rd.
Mentor,  OH  44060
Applicant Contact Anthony Piotrkowski
Correspondent
STERIS Corporation
5960 Heisley Rd.
Mentor,  OH  44060
Correspondent Contact Anthony Piotrkowski
Regulation Number880.2800
Classification Product Code
JOJ  
Date Received09/30/2016
Decision Date 03/21/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-