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510(k) K112093

Device
CRYOMATIC CRYO CONSOLE, DISPOSABLE CRYO PROBE, DISPOSABLE PROBE ADAPTER
Applicant
KEELER INSTRUMENTS, INC.
510(k) number
K112093
Product code
HRN  
Decision
Substantially Equivalent (SESE)
Decision date
2011-12-08
Date received
2011-07-22
Regulation
886.4170
Classification name
Unit, Cryophthalmic, Ac-powered
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
EUGENE R VANARSDALE
Address
456 Pkwy. Broomall PA US 19008 19008

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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
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
K823768CLIRANS TE08 HOLLOW FIBER DIALYZERTerumo Medical Corp.1983-01-08

Legacy Summary#

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FDA Review#

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