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510(k) K131893

Device
AMICO CE SERIES SURGICAL LIGHTS, MIRA LED SERIES MINOR SURGICAL LIGHTS
Applicant
AJW TECHNOLOGY CONSULTANTS, INC.
510(k) number
K131893
Product code
FSY  
Decision
Substantially Equivalent (SESE)
Decision date
2013-10-30
Date received
2013-06-25
Regulation
878.4580
Classification name
Light, Surgical, Ceiling Mounted
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
JANET DOUGLAS
Address
445 Apollo Beach Blvd. Apollo Beach FL US 33572 33572

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code FSY  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K142984Leo MinorSunnex, Inc.2014-10-29
K142076CLAVEGUARD FREEDOM SURGICAL LIGHTDickson & Dickson Healthcare (Us), Inc.2014-09-30
K140812MI-750 PROCEDURAL/MINOR SURGICAL LIGHTMedical Illumination International, Inc.2014-08-07
K132551ZF 720Umbel Corporation2014-06-30
K140930VIDA LED SURGICAL LIGHTING SYSTEM, V SERIESConvida Healthcare & Systems Corporation2014-06-09
K140461MACH LED 2MCDr. Mach GmbH & Co. KG2014-04-03
K140460MACH LED 2SCDr. Mach GmbH & Co. KG2014-04-03
K132747VISUM BLADE LED SURGICAL LIGHTING SYSTEMStryker Communications2013-12-30
K132307VIDA LED SURGICAL LIGHTING SYSTEMConvida Healthcare & Systems Corporation2013-11-05
K122875ORICARE L2700Oricare, Inc.2012-12-18
K120392CHROMOPHARE F 628 AND F 528Berchtold GmbH & Co. KG2012-02-16
K102758TRULIGHT 5520 AND TRULIGHT 5320Trumpf Kreuzer Medizin Systeme GmbH + Co.Kg2010-10-26
K101537AIM 200, MAJOR SURGICAL LIGHTBurton Medical Products Corp.2010-09-30
K100702STARTROL LED LIGHTING SYSTEMS (X=# OF PODS, Y=# OF LEDS, N=TO MOUNTING STYLE) MODEL X X Y -N-S-W. X=NUMBER OF LIGHT PODSHuot Instruments, LLC2010-07-20
K093009MACH LED SCDr. Mach GmbH & Co. KG2010-04-01

Legacy Summary#

summary

FDA Review#

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