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510(k) K770251

Device
SUPER X ADJUSTRETTE
Applicant
Qualitone
510(k) number
K770251
Product code
EXD
Decision
Substantially Equivalent (SESE)
Decision date
1977-02-28
Date received
1977-02-09
Regulation
876.5895
Classification name
Irrigator, Ostomy
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Traditional
Third party reviewed
N

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code EXD#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K121833OSTOMY IRRIGATION SETColoplast A/S2012-07-16
K914692URINARY DIVERSION EVACUATING CATHETERCook Urological, Inc.1992-07-02
K904586PALEX IRRIGATION SETPalex Intl. SA1990-12-28
K871791BLOXOM IRRIGATORI.B. Bloxom C/O Hogan & Hartson1987-05-20
K840268IRRIGATION SYSTEMColoplast A/S1984-04-05
K832299VISI-FLOW IRRIGATORConvatec, A Division of E.R. Squibb & Sons1983-08-26
K823274UNI-TIP COLOSTOMY IRRIGATION CONEHowmedica Corp.1982-12-07
K811160SUR-FIT IRRIGATION SLEEVEE. R. Squibb & Sons, Inc.1981-06-02
K790749COLOSTOMY ENEMA DEVICEVabar Corp.1979-05-16
K790750COLOSTOMY DEVICE W/ PRESSURE LIDVabar Corp.1979-05-14
K760810TUBE, GASTRO-ENTEROSTOMYSherwood Medical Industries1977-02-28