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510(k) K202038

Device
CryoTreQ
Applicant
VitreQ B.V.
510(k) number
K202038
Product code
HPS  
Decision
Substantially Equivalent (SESE)
Decision date
2020-12-30
Date received
2020-07-23
Regulation
886.4170
Classification name
Unit, Cryophthalmic
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Christian Neele
Address
Segglant-Noord 2 Vierpolders NL 3237MG 3237MG

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code HPS  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
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
K873388KEELER CTU CRYO SYSTEMKeeler Instruments, Inc.1987-11-13
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#

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FDA Review#

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