• 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 Tubes, Gastrointestinal (And Accessories)
510(k) Number K983476
Device Name BIONAVIGATION SYSTEM FOR PLACEMENT OF ENTERAL FEEDING TUBES
Applicant
NAVION BIOMEDICAL CORP.
312 TOSCA DR.
STOUGHTON,  MA  02072
Applicant Contact DONALD A KAY
Correspondent
NAVION BIOMEDICAL CORP.
312 TOSCA DR.
STOUGHTON,  MA  02072
Correspondent Contact DONALD A KAY
Regulation Number876.5980
Classification Product Code
KNT  
Date Received10/02/1998
Decision Date 03/01/1999
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
-
-