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510(k) K130819

Device
CLL- V1 LIGHT SOURCE
Applicant
OLYMPUS WINTER & IBE GMBH
510(k) number
K130819
Product code
NTN  
Decision
Substantially Equivalent (SESE)
Decision date
2013-06-19
Date received
2013-03-25
Regulation
876.1500
Classification name
Led Light Source
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
SHERI L MUSGNUNG
Address
3500 Corporate Pkway Center Valley PA US 18034 18034

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code NTN  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K141164ARTEMIS LIGHT ENGINEQuest Medical Imaging2015-03-16
K133311ENDOLEDOlympus Winter & Ibe GmbH2014-07-30
K122831VIDEO SYSTEM CENTEROlympus Medical Systems Corp.2012-12-14
K113679LUCEA LED SURGICAL LIGHT SYSTEMMaquet S.A.S.2012-01-12
K103813SOPRO 281Sopro2011-03-22
K102167LO-50 LED LIGHT SOURCEFiberoptics Technology, Inc.2010-08-17
K091829PLS PORTABLE LIGHT SOURCEOptim, Inc.2009-07-28
K090601FSC 2Schoelly Imaging, Inc.2009-05-11

Legacy Summary#

summary

FDA Review#

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