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510(k) K770568

Device
SURGICAL ILLUMINATOR (SIL)
Applicant
FIBER OPTICS ENGINEERING, INC.
510(k) number
K770568
Product code
FTD  
Decision
Substantially Equivalent (SESE)
Decision date
1977-04-14
Date received
1977-03-25
Regulation
878.4580
Classification name
Lamp, Surgical
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code FTD  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K133425SCINTILLANT DUAL BENT TIP SURGICAL LIGHT, SCINTILLANT DUAL STRAIGHT TIP SURGICAL LIGHTEngineered Medical Solutions Co., LLC2013-12-05
K130513VOLISTA 400; VOLISTA 600Maquet S.A.S.2013-05-08
K123776POLARIS 100/200Drager Medical GmbH2013-03-08
K111020ATRICURE DISSECTORAtriCure, Inc.2011-06-09
K100234HM-LAMP IIHillusa, Inc.2010-07-08
K100884STRYKER KNIFELIGHTHowmedica Osteonics Corp.2010-06-25
K071180SCINTILLANT SURGICAL LIGHT, MODEL 2644-01-0001Engineered Medical Solutions Co., LLC2007-06-20
K053364HALUX IRIS EXAMINATION AND SURGICAL LAMPWaldmann Lighting2006-02-23
K041681ATRICURE DISSECTORAtriCure, Inc.2004-07-01
K013242AMSCO HARMONY SURGICAL LIGHTING AND MEDIA SYSTEMSTERIS Corporation2001-12-13
K010724SOLA 700,SOLA 500, SOLA 300Drager Medizintechnik GmbH2001-06-07
K003423ST. FRANCIS OPERATING THEATRE LAMP, MODELS OLH01-125 AND LC-055St. Francis Medical Equipment Co., Ltd.2001-02-22
K981717STRYKER KNIFELIGHT, STRYKER ILLUMINATED RETRACTORStryker Instruments1998-06-30
K961122STRYKER KNIFELIGHTStryker Instruments1996-08-22
K954263XE-LITEOphthalmic Technologies, Inc.1995-10-18

Legacy Summary#

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FDA Review#

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