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 Tube, Feeding
510(k) Number K072881
Device Name NEOMED Enteral FEEDING TUBE
Applicant
Neomed, Inc.
717 Lakeglen Dr.
Swanee,  GA  30024
Applicant Contact PENNY NORTHCUTT
Correspondent
Neomed, Inc.
717 Lakeglen Dr.
Swanee,  GA  30024
Correspondent Contact PENNY NORTHCUTT
Regulation Number876.5980
Classification Product Code
FPD  
Date Received10/09/2007
Decision Date 01/09/2008
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
-
-