FDA.reportPublic FDA data

510(k) K873388

Device
KEELER CTU CRYO SYSTEM
Applicant
KEELER INSTRUMENTS, INC.
510(k) number
K873388
Product code
HPS  
Decision
Substantially Equivalent (SESE)
Decision date
1987-11-13
Date received
1987-08-24
Regulation
886.4170
Classification name
Unit, Cryophthalmic
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 HPS  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K202038CryoTreQVitreQ BV2020-12-30
K940373OPHTHALMIC CRYO UNITDutch Ophthalmic USA, Inc.1994-07-18
K923629OPHTHALMIC TRICHIASIS PROBEMira, Inc.1992-10-19
K903303SPEMBLY MEDICAL 242 CRYOUNIT/SERIES 242 CRYOPROBESSpembly Medical , Ltd.1990-10-11
K874555KEELER ACU 22XT OPHTHALMIC CRYO UNITKeeler Instruments, Inc.1988-01-29
K870195UNITED SURGICAL CORP. CRYOPTIC PLUSUnited Surgical Corp.1987-02-20
K833747GALLIE CRYONUCLEATORMono Research Laboratories1984-05-09
K801418KEELER AMOILS ACULL CRYO OPHTHALMIC UNITKeeler Optical Products , Ltd.1980-07-21
K781338BEAVER CATARACT CYROXTRACTOREdward Weck, Inc.1979-02-12
K790102MODEL 556-01 CRYOEXTRACTORIntermedics, Inc.1979-02-12

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