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510(k) K904299

Device
SLIM LINE RETENT TIP W/SILICONE INFLATION CUFF
Applicant
E-Z-EM, INC.
510(k) number
K904299
Product code
FGD  
Decision
Substantially Equivalent (SESE)
Decision date
1990-11-27
Date received
1990-09-19
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
GEORGANNE BROWN
Address
373 Plantation St. Worcester MA US 01605 01605

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
K905026DUAL FLEX NON-LATEXMmi, Inc.1991-12-18
K905574SLIM LINE RETENTION TIP W/ SILICONE RUBBER CUFFE-Z-Em, Inc.1991-01-24
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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