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 gastrointestinal tubes with enteral specific connectors
510(k) Number K181787
Device Name Cediflo Enteral Feeding Tubes & Cediflo Junior Enteral Feeding Tubes
Applicant
Cedic S.r.l.
Via Liberazione, 63/9
Peschiera Borromeo,  IT 20068
Applicant Contact Tiziana Melis
Correspondent
Koelper Consulting LLC
268 Baltimore Drive
North Barrington,  ID  60010
Correspondent Contact Crystal Koelper
Regulation Number876.5980
Classification Product Code
PIF  
Date Received07/05/2018
Decision Date 04/25/2019
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
-
-