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510(k) K060734

Device
FRESENIUS COM.TEC AUTOMATED CELL SEPARATOR, MODEL 9008031; FRESENIUS C5L, S5L, C5L-T PLATELET SETS (5-DAY STORAGE)
Applicant
FRESENIUS MEDICAL CARE NORTH AMERICA
510(k) number
K060734
Product code
LKN  
Decision
Substantially Equivalent (SESE)
Decision date
2006-09-05
Date received
2006-03-20
Regulation
510(k) Premarket Notification
Classification name
Separator, Automated, Blood Cell And Plasma, Therapeutic
Medical specialty
510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices
Review panel
Gastroenterology/Urology
Device class
U
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
JANET C KAY
Address
95 Hayden Ave. Lexington MA US 02420 02420

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code LKN  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K192150AMICUS Separator SystemFresenius Kabi AG2019-11-13
K183081Spectra Optia Apheresis SystemTerumobct, Inc.2019-02-05
K180615AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer Set, Blood Component Filter Set With Vented Spike and Luer AdapterFresenius Kabi USA,Llc2018-12-04
K181049Spectra Optia Apheresis SystemTerumobct, Inc.2018-11-01
K172590Spectra Optia Apheresis SystemTerumobct, Inc.2018-03-02
K153601Spectra Optia Apheresis SystemTerumobct, Inc.2016-01-14
K151368Spectra Optia Apheresis System, Spectra Optia Exchange Set (with AC Connection), Spectra Optia AC Connection AdapterTerumo Bct2015-09-11
K141938SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA EXCHANGE SET (DISPOSABLE BLOOD TUBING SET)Terumobct, Inc.2015-03-23
K141019AMICUS SEPARATOR SYSTEM/ AMICUS SEPERATOR SYSTEM;REFURBISHEDFenwal, Inc.2014-06-10
K132429SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA SYSTEM SOFTWARE, SPECTRA OPTIA EXCHANGE DISPOSABLE SETTerumobct, Inc.2013-12-06
K131744SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA SINGLE-NEEDLE CONNECTOR, SPECTRA OPTIA SYSTEM SOFTWARETerumobct, Inc.2013-08-08
K111702AMICUS SEPARATOR SYSTEM- USE IN THERAPEUTIC PLASMA EXCHANGE AND FILTER SET FOR AMICUS TPEFenwal, Inc.2012-03-22
K113480SPECTRA OPTIA APHERESIS SYSTEMCaridianbct, Inc..2012-01-20
K103090SPECTRA OPTIA R APHERESIS SYSTEMCaridianbct, Inc..2010-11-19
K071079SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA EXCHANGE SET, MODEL 61000, 10200Gambro Bct, Inc.2007-08-02

Legacy Summary#

summary

FDA Review#

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