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510(k) K980808

Device
ENDO FMS UROLOGY
Applicant
FUTURE MEDICAL SYSTEMS, INC.
510(k) number
K980808
Product code
LJH  
Decision
Substantially Equivalent (SESE)
Decision date
1998-05-08
Date received
1998-03-03
Regulation
876.5130
Classification name
System, Irrigation, Urological
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
PATRICK JANIN
Address
504 Mccormick Dr. Suite T Glen Burnie MD US 21061 21061

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code LJH  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K162992Karl Storz UROMAT E.A.S.I.Karl Storz Endoscopy America, Inc.2017-07-07
K070873AMSURE BLADDER IRRIGATION SETAmsino Intl., Inc.2007-12-19
K071832MODIFCATION TO: SPYGLASS IRRIGATION SYSTEMMedical Scientific, Inc.2007-09-18
K063700SPYGLASS IRRIGATION SYSTEMMedical Scientific, Inc.2007-02-08
K062551NEXUS IRRIGATION TUBING SETNexus Medical, LLC2006-12-15
K042457URO PROW.O.M. World of Medicine AG2004-10-25
K040094PIGGYBACK IRRIGATING SYSTEMKosin Technologies, LLC2004-04-15
K023808IRRIGATION SETSInternational Medsurg Connection2003-03-10
K010607MED-RX IRRIGATION SET, MODEL 10-3001, 10-3002, 10-4000, 10-4001Benlan, Inc.2001-11-28
K010122CONTINUOUS FLOW Y-TUBINGG.U.-Tek2001-06-04
K001325FLO ASSISTANT, MODEL 4-250-00Northgate Technologies, Inc.2000-08-18
K990909MTP UROPUMP DISPOSABLE TUBING SETMtp Medical Technical Promotion GmbH1999-06-09
K981615KSEA UROPUMPKARL STORZ Endoscopy-America, Inc.1998-07-08
K971982KARL STORZ MODEL 203020 20 EQUIMATKARL STORZ Endoscopy-America, Inc.1997-08-12
K970946MEDLINE Y-TYPE TUR/BLADDER IRRIGATION SETMedline Industries, Inc.1997-06-10

Legacy Summary#

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FDA Review#

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