FDA.reportPublic FDA data

510(k) K854411

Device
KEELER-COMPACT CRYO SYSTEM
Applicant
KEELER INSTRUMENTS, INC.
510(k) number
K854411
Product code
HQA  
Decision
Substantially Equivalent (SESE)
Decision date
1985-12-30
Date received
1985-11-01
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#

Contact
VAN ARSDALE
Address
456 Pkwy. Broomall PA US 19008 19008

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
K854422SERIES 25 SLIMLINE CRYO PROBESKeeler Instruments, Inc.1985-12-30
K841294ACU220 CRYO UNITKeller Instruments, Inc.1984-08-15
K823835SPEMBLY 140 CRYOSYSTEM PROBES & TIPSKeller Instruments, Inc.1983-01-17

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases