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 K141631
Device Name AQUARIUS EXTENSION FEEDING SET
Applicant
DEGANIA SILICONE, LTD.
KIBBUTZ DEGANIA BET
EMEK HAYARDEN,  IL 1513000
Applicant Contact ZOYA LEE
Correspondent
DEGANIA SILICONE, LTD.
KIBBUTZ DEGANIA BET
EMEK HAYARDEN,  IL 1513000
Correspondent Contact ZOYA LEE
Regulation Number876.5980
Classification Product Code
KNT  
Date Received06/18/2014
Decision Date 07/28/2014
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-