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510(k) K841294

Device
ACU220 CRYO UNIT
Applicant
KELLER INSTRUMENTS, INC.
510(k) number
K841294
Product code
HQA  
Decision
Substantially Equivalent (SESE)
Decision date
1984-08-15
Date received
1984-03-29
Regulation
886.4170
Classification name
Unit, Cryotherapy, Ophthalmic
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
4221 Richmond Rd., NW Walker MI US 49534 49534

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HQA  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K854411KEELER-COMPACT CRYO SYSTEMKeeler Instruments, Inc.1985-12-30
K854422SERIES 25 SLIMLINE CRYO PROBESKeeler Instruments, Inc.1985-12-30
K823835SPEMBLY 140 CRYOSYSTEM PROBES & TIPSKeller Instruments, Inc.1983-01-17

Legacy Summary#

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FDA Review#

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