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510(k) K905026

Device
DUAL FLEX NON-LATEX
Applicant
MMI, INC.
510(k) number
K905026
Product code
FGD  
Decision
Substantially Equivalent (SESE)
Decision date
1991-12-18
Date received
1990-11-07
Regulation
876.5980
Classification name
Catheter, Retention, Barium Enema With Bag
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
MATTLER
Address
19500 W. Eight Mile Rd. P.O. Box 305 Southfield MI US 48037 48037

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code FGD  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K223890NAJA Gastrointestinal CatheterChess Medical, Inc.2023-06-16
K905574SLIM LINE RETENTION TIP W/ SILICONE RUBBER CUFFE-Z-Em, Inc.1991-01-24
K904299SLIM LINE RETENT TIP W/SILICONE INFLATION CUFFE-Z-Em, Inc.1990-11-27
K884379MAGLINTE ENTEROCLYSIS CATHETERLafayette Pharmacal, Inc.1989-02-28
K872006DISPOSABLE BARIUM ENEMA TIP WITH RETENTION CUFFMac Lee Medical Products1987-11-17

Legacy Summary#

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FDA Review#

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