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510(k) K980005

Device
MANAN D BAG
Applicant
MEDICAL DEVICE TECHNOLOGIES, INC.
510(k) number
K980005
Product code
EXF  
Decision
Substantially Equivalent (SESE)
Decision date
1998-01-30
Date received
1998-01-02
Regulation
876.5010
Classification name
Bag, Bile Collecting
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
KARL SWARTZ
Address
4445 SW 35th Ter. Suite 310 Gainsville FL US 32608 32608

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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
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
K911129MMG BILE BAGMedical Technologies of Georgia1991-08-07
K903449URESIL TRU-CLOSE MULTI-PURPOSE DRAINAGE SETUresil Corp.1990-09-12
K901844URESIL TRU-CLOSE DRAINAGE BAGUresil Corp.1990-06-01

Legacy Summary#

summary

FDA Review#

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