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 K210279
Device Name Enbio S
Applicant
Enbio Group AG
Eichengasse 3
Oensingen,  CH CH-4702
Applicant Contact Lukasz Rogowski
Correspondent
Enbio Group AG
Eichengasse 3
Oensingen,  CH CH-4702
Correspondent Contact Lukasz Rogowski
Regulation Number880.6880
Classification Product Code
FLE  
Date Received02/01/2021
Decision Date 10/29/2021
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
-
-