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510(k) K841331

Device
OLYMPUS KC-10 MOBILE DISINFEC-STAT
Applicant
KEYMED, INC.
510(k) number
K841331
Product code
NZA  
Decision
Substantially Equivalent (SESE)
Decision date
1984-07-19
Date received
1984-04-02
Regulation
876.1500
Classification name
Accessories, Germicide, Cleaning, For Endoscopes
Medical specialty
Gastroenterology/Urology
Review panel
General Hospital
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 NZA  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K232918enspire 300 Series Automated Endoscope ReprocessorSTERIS Corporation2023-10-03
K230560enspire 300 Series Automated Endoscope Reprocessor SystemSTERIS Corporation2023-07-21
K220361Reliance EPS Endoscope Processing System and Reliance DG Dry GermicideSTERIS Corporation2022-03-10
K203223Reliance EPS Endoscope Processing System and Reliance DG Dry GermicideSteris2021-01-28
K200989Reliance Endoscope Processing SystemSTERIS Corporation2020-05-14
K123768RELIANCE ADVANCE ENDOSCOPE PROCESSING SYSTEMSTERIS Corporation2013-07-26
K110453RELIANCE ENDOSCOPE PROCESSING SYSTEMSTERIS Corporation2011-03-16
K102244RELIANCE ENDOSCOPE PROCESSING SYSTEMSTERIS Corporation2010-12-03
K040049THE RELIANCE ENDOSCOPE PROCESSING SYSTEMSTERIS Corporation2004-12-17
K860704THE KEYMED SIGMOIDOSCOPE DISINFECTION STANDKeymed, Inc.1986-06-17

Legacy Summary#

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FDA Review#

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