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 Enteral Specific Transition Connectors
510(k) Number K162254
Device Name Cedic Enteral ENFit Transition Connectors
Applicant
Cedic S.R.L.
Via Liberazione, 63/9
Peschiera Borromeo,  IT 20068
Applicant Contact TIZIANA MELIS
Correspondent
Donawa Lifescience Consulting Srl
Piazza Albania 10
Rome,  IT 00153
Correspondent Contact ROGER GRAY
Regulation Number876.5980
Classification Product Code
PIO  
Date Received08/10/2016
Decision Date 05/04/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-