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 syringes with enteral specific connectors
510(k) Number K161811
Device Name Medela Low Dose Enteral Syringe
Applicant
Medela, Inc.
785 Challenger Street
Brea,  CA  92821
Applicant Contact Fergie Ferguson
Correspondent
Medela, Inc.
785 Challenger Street
Brea,  CA  92821
Correspondent Contact Fergie Ferguson
Regulation Number876.5980
Classification Product Code
PNR  
Subsequent Product Code
FMF  
Date Received07/01/2016
Decision Date 02/15/2017
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
Recalls CDRH Recalls
-
-