• 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 K120272
Device Name AMERITUS MEDICAL ENTERAL FEEDING EXTENSION SET
Applicant
KENTEC MEDICAL, INC.
17871 fitch
irvine,  CA  92614 -6001
Applicant Contact keith rooks
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1394 25th street, nw
buffalo,  MN  55313
Correspondent Contact mark job
Regulation Number876.5980
Classification Product Code
KNT  
Date Received01/30/2012
Decision Date 02/17/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
summary summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
-
-