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 K890093
Device Name PVC EMPTY SOLUTION CONTAINER ENTERAL PUMP SET
Applicant
KELLS MEDICAL, INC.
1518 - CONESTOGA COURT
REDLANDS,  CA  92373
Applicant Contact M GREY
Correspondent
KELLS MEDICAL, INC.
1518 - CONESTOGA COURT
REDLANDS,  CA  92373
Correspondent Contact M GREY
Regulation Number876.5980
Classification Product Code
KNT  
Date Received01/10/1989
Decision Date 07/24/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-