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 K171347
Device Name Bi-Funnel and Tri-Funnel Gastrostomy Feeding Tubes with ENFit Connection, Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection
Applicant
Xeridiem Medical Devices
4700 S. Overland Dr.
Tucson,  AZ  85714
Applicant Contact Steve Murray
Correspondent
Xeridiem Medical Devices
4700 S. Overland Dr.
Tucson,  AZ  85714
Correspondent Contact Steve Murray
Regulation Number876.5980
Classification Product Code
PIF  
Subsequent Product Code
KNT  
Date Received05/08/2017
Decision Date 06/06/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-