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 Pouch, Colostomy
510(k) Number K880327
Device Name MARLEN ULTRA ILEOSTOMY POUCH-5000
Applicant
Marlen Mfg. & Development Co.
5150 Richmond Rd.
Bedford,  OH  44146
Applicant Contact FENTON
Correspondent
Marlen Mfg. & Development Co.
5150 Richmond Rd.
Bedford,  OH  44146
Correspondent Contact FENTON
Regulation Number876.5900
Classification Product Code
EZQ  
Date Received01/26/1988
Decision Date 02/19/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-