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, Nasogastric
510(k) Number K930510
Device Name RADIUS ENTERAL FEEDING TUBE
Applicant
Radius Intl., Inc.
21860 W. Washington St.
Grayslake,  IL  60030
Applicant Contact DAVID G QUINN
Correspondent
Radius Intl., Inc.
21860 W. Washington St.
Grayslake,  IL  60030
Correspondent Contact DAVID G QUINN
Regulation Number876.5980
Classification Product Code
BSS  
Date Received02/01/1993
Decision Date 02/01/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-