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510(k) K823768

Device
CLIRANS TE08 HOLLOW FIBER DIALYZER
Applicant
TERUMO MEDICAL CORP.
510(k) number
K823768
Product code
HRN  
Decision
Substantially Equivalent (SESE)
Decision date
1983-01-08
Date received
1982-12-14
Regulation
886.4170
Classification name
Unit, Cryophthalmic, Ac-powered
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
125 Blue Ball Rd. Elkton MD US 21921 21921

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HRN  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K200911MIRA AdapterPhakos2020-06-02
K180195Frigitronics adapterPhakos2018-03-16
K162756PHAKOS Disposable Retinal Cryo ProbePhakos2017-05-03
K160591D.O.R.C. Disposable Cryo ProbeDutch Ophthalmic Research Center International BV2017-01-23
K131787CRYOMATIC MKII CONSOLE, CRYOMATIC MKII PROBES, DISPOSABLE CRYO PROBESKeeler, Ltd.2013-12-23
K112093CRYOMATIC CRYO CONSOLE, DISPOSABLE CRYO PROBE, DISPOSABLE PROBE ADAPTERKeeler Instruments, Inc.2011-12-08
K062412CRYOMATICKeeler Instruments, Inc.2006-11-06
K012821D.O.R.C. CRYOSTAR CRYOSURGICAL SYSTEMDutch Ophthalmic USA, Inc.2001-10-22
K992954KEELER CRYO MASTER & PROBESKeeler Instruments, Inc.1999-12-21

Legacy Summary#

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FDA Review#

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