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510(k) K083785

Device
VITALA CONTINENCE CONTROL DEVICE
Applicant
CONVATEC
510(k) number
K083785
Product code
EZQ  
Decision
Substantially Equivalent (SESE)
Decision date
2010-04-02
Date received
2008-12-19
Regulation
876.5900
Classification name
Pouch, Colostomy
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
MARILYN KONICKY
Address
200 Headquarters Park Dr. Skillman NJ US 08558 08558

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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
K9224014 SURE TM COLOSTOMY POUCHBoston Pacific Medical, Inc.1992-06-10
K880327MARLEN ULTRA ILEOSTOMY POUCH-5000Marlen Mfg. & Development Co.1988-02-19
K863830CONSEAL(TM) COLOSTOMY CONTINENCE SYSTEMColoplast A/S1986-10-16

Legacy Summary#

summary

FDA Review#

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