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 irrigator, ostomy
510(k) Number K904586
Device Name PALEX IRRIGATION SET
Applicant
PALEX INTL. SA
CARRETERA DE TERRASSA, 121
08191 RUBI' (BARCELONA)
SPAIN,  ES
Applicant Contact MARTIN A JORDAN
Correspondent
PALEX INTL. SA
CARRETERA DE TERRASSA, 121
08191 RUBI' (BARCELONA)
SPAIN,  ES
Correspondent Contact MARTIN A JORDAN
Regulation Number876.5895
Classification Product Code
EXD  
Date Received10/09/1990
Decision Date 12/28/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-