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 Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
510(k) Number K112536
Device Name SONICISION STERILIZATION TRAY
Applicant
Covidien
5920 Longbow Dr.
Boulder,  CO  80301
Applicant Contact DAVID M HORTON
Correspondent
Covidien
5920 Longbow Dr.
Boulder,  CO  80301
Correspondent Contact DAVID M HORTON
Regulation Number880.6850
Classification Product Code
KCT  
Date Received09/01/2011
Decision Date 04/19/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-