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 Tubes, Gastrointestinal (And Accessories)
510(k) Number K855097
Device Name COMPAT ENTERAL DELIVERY SYSTEMS
Applicant
Sandoz Nutrition
5320 W. Twenty Third St.
P.O. Box 370
Minneapolis,  MN  55440
Applicant Contact LONGLEY PH.D.
Correspondent
Sandoz Nutrition
5320 W. Twenty Third St.
P.O. Box 370
Minneapolis,  MN  55440
Correspondent Contact LONGLEY PH.D.
Regulation Number876.5980
Classification Product Code
KNT  
Date Received12/23/1985
Decision Date 04/08/1986
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
-
-