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 Sterilant, Medical Devices
510(k) Number K013280
Device Name STERILOX LIQUID CHEMICAL STERILANT SYSTEM
Applicant
Sterilox Technologies, Inc.
Heston Hall/Carriage House
1790 Yardley-Langhorne Rd.
Yardley,  PA  19067
Applicant Contact HOWARD MANN
Correspondent
Citech
5200 Butler Pike
Plymouth Meeting,  PA  19462 -1298
Regulation Number880.6885
Classification Product Code
MED  
Date Received10/02/2001
Decision Date 09/18/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-