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 catheter, retention, barium enema with bag
510(k) Number K904299
Device Name SLIM LINE RETENT TIP W/SILICONE INFLATION CUFF
Applicant
E-Z-EM, INC.
373 PLANTATION ST.
WORCESTER,  MA  01605
Applicant Contact GEORGANNE BROWN
Correspondent
E-Z-EM, INC.
373 PLANTATION ST.
WORCESTER,  MA  01605
Correspondent Contact GEORGANNE BROWN
Regulation Number876.5980
Classification Product Code
FGD  
Date Received09/19/1990
Decision Date 11/27/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-