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 sterilizer, chemical
510(k) Number K083097
Device Name AMSCO V-PRO 1 LOW TEMPERATURE STERILIZATION SYSTEM
Applicant
STERIS Corporation
5960 Heisley Road
Mentor,  OH  44060
Applicant Contact JOHN R SCOVILLE
Correspondent
STERIS Corporation
5960 Heisley Road
Mentor,  OH  44060
Correspondent Contact JOHN R SCOVILLE
Regulation Number880.6860
Classification Product Code
MLR  
Date Received10/17/2008
Decision Date 08/03/2009
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
Recalls CDRH Recalls
-
-