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510(k) K880327

Device
MARLEN ULTRA ILEOSTOMY POUCH-5000
Applicant
MARLEN MFG. & DEVELOPMENT CO.
510(k) number
K880327
Product code
EZQ  
Decision
Substantially Equivalent (SESE)
Decision date
1988-02-19
Date received
1988-01-26
Regulation
876.5900
Classification name
Pouch, Colostomy
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
FENTON
Address
5150 Richmond Rd. Bedford OH US 44146 44146

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code EZQ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K111365VITALA CONTINENCE CONTROL DEVICEConvatec, Inc.2011-08-19
K102536VITALA CONTINENCE CONTROL DEVICEConvatec, Inc.2010-12-01
K083785VITALA CONTINENCE CONTROL DEVICEConvatec2010-04-02
K9224014 SURE TM COLOSTOMY POUCHBoston Pacific Medical, Inc.1992-06-10
K863830CONSEAL(TM) COLOSTOMY CONTINENCE SYSTEMColoplast A/S1986-10-16

Legacy Summary#

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FDA Review#

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