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, Steam
510(k) Number K213080
Device Name T-Edge 10, T-Edge 11
Applicant
Tuttnauer , Ltd.
Har-Tuv Industrial Zone
Beit-Shemesh,  IL 9910101
Applicant Contact Robert Basile
Correspondent
Tuttnauer , Ltd.
Har-Tuv Industrial Zone
Beit-Shemesh,  IL 9910101
Correspondent Contact Robert Basile
Regulation Number880.6880
Classification Product Code
FLE  
Date Received09/23/2021
Decision Date 01/04/2022
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
-
-