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510(k) K834437

Device
KEATES IRRIGATION/ASPIRATION/VITREOUS
Applicant
FRIGITRONICS OF CONNECTICUT, INC.
510(k) number
K834437
Product code
HQE  
Decision
Substantially Equivalent (SESE)
Decision date
1984-03-30
Date received
1983-12-19
Regulation
886.4150
Classification name
Instrument, Vitreous Aspiration And Cutting, Ac-powered
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 HQE  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K212763UniVit HE, UniVit UHSVisioncare Devices, LLC2022-08-10
K170183Cetus system, Cetus probeA.R.C Laser GmbH2017-09-27
K153168Bi-Blade Vitrectomy CutterMedical Instrument Development Laboratories2016-04-29
K141065CONSTELLATION VISION SYSTEMAlcon Research, Ltd.2014-08-22
K121675VERSAVITSynergetics, Inc.2012-06-21
K120170PROCARE PLUS VITRECTOMY SYSTEMVisioncare Devices, Inc.2012-05-30
K102222ULTIMATE VIT ENHAMCER (UVE)Medical Instrument Development Laboratories, Inc.2011-04-08
K033390COLIBRI DISPOSABLE VITRECTOMY CUTTERMicroworld Medical Instruments, Inc.2003-11-04
K030948VMATE MODEL VMM1000Howard Instruments, Inc.2003-06-17
K023939VELOCITY ADVANTAGEVisioncare Devices, Inc.2003-04-17
K020911MID LABS AUTONOMOUS VIT ENHANCER (AVE)Medical Instrument Development Laboratories, Inc.2002-04-29
K010082D.O.R.C. HARMONY TOTAL TTC VITRECTOMY SYSTEMDutch Ophthalmic USA, Inc.2001-03-12
K992943VIT ENHANCERMedical Instrument Development Laboratories, Inc.1999-12-10
K990292I/A (IRRIGATION/ASPIRATION) PACK, POSTERIOR VITRECOMY PACK, ANTERIOR VIRECTOMY PACK, PHACOEMULSIFICATION PACK, ADMIINISNOphthalmic Consultants, Inc.1999-11-19
K983797D.O.R.C. HARMONY TOTAL VITRECTOMY SYSTEMDutch Ophthalmic USA, Inc.1999-03-03

Legacy Summary#

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FDA Review#

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