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 K895329
Device Name 600ML AND 1200ML ENTERAL BAG ADM. SET FOR ENTERA
Applicant
DELMED, INC.
120 ALBANY ST.
P.O. BOX 2623
NEW BRUNSWICK,  NJ  08903
Applicant Contact SUSAN REVELJ
Correspondent
DELMED, INC.
120 ALBANY ST.
P.O. BOX 2623
NEW BRUNSWICK,  NJ  08903
Correspondent Contact SUSAN REVELJ
Regulation Number876.5980
Classification Product Code
KNT  
Date Received08/31/1989
Decision Date 10/02/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-