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510(k) K911129

Device
MMG BILE BAG
Applicant
MEDICAL TECHNOLOGIES OF GEORGIA
510(k) number
K911129
Product code
EXF  
Decision
Substantially Equivalent (SESE)
Decision date
1991-08-07
Date received
1991-03-14
Regulation
876.5010
Classification name
Bag, Bile Collecting
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
TIMOTHY D GOLDEN
Address
5335 Dividend Dr. Decatur GA US 30035 30035

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code EXF  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K003078MERIT DRAINAGE DEPOTMerit Medical Systems, Inc.2000-12-11
K990428DRAINAGE BAGRemington Medical, Inc.1999-08-12
K980005MANAN D BAGMedical Device Technologies, Inc.1998-01-30
K961986MANAN D BAGManan Medical Products, Inc.1997-03-13
K963849MANAN D BAGManan Medical Products, Inc.1996-12-13
K943663NAVARRE 600 ML DRAINAGE BAGNavarre Biomedical , Ltd.1994-09-08
K903449URESIL TRU-CLOSE MULTI-PURPOSE DRAINAGE SETUresil Corp.1990-09-12
K901844URESIL TRU-CLOSE DRAINAGE BAGUresil Corp.1990-06-01

Legacy Summary#

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FDA Review#

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