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510(k) K935226

Device
I/V POLE
Applicant
OPTICAL MICRO SYSTEMS, INC.
510(k) number
K935226
Product code
KYG  
Decision
Substantially Equivalent (SESE)
Decision date
1994-02-16
Date received
1993-11-01
Regulation
886.4360
Classification name
Device, Irrigation, Ocular Surgery
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
RONALD LUICH
Address
86 Boston Post Rd. Waterford CT US 06385 06385

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KYG  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K010353MED-LOGICS DISPOSABLE ALK TUBINGMed-Logics, Inc.2001-04-27
K003036TURBO-FLOW INFUSION CANNULA 19 GAGE,20 GAGE,23 GAGE, 25 GAGE, MODEL 101019,101020,101023,101025Retinalabs.Com2000-12-22
K993591BLADEWORKS DISPOSABLE ALK TUBINGBlade Works, Inc.1999-12-28
K981116SOVEREIGN CATARACT EXTRACTION SYSTEMAllergan, Inc.1998-05-19
K980647EYE IRRIGATOR MODEL #2020Eye-Deal Ocular Safety Products, Inc.1998-05-15
K974561MOISTAIR FLUID AIR TUBING SETAmerican Medical Devices, Inc.1998-02-19
K971173ML DISPOSABLE ALK TUBINGMed-Logics, Inc.1997-05-22
K970161HEDGES CORNEAL WETTING PAKHedges Cwp, Inc.1997-03-25
K954842D.O.R.C. VFI/VFE SYSTEMDutch Ophthalmic USA, Inc.1996-04-15
K945171DISPOSABLE & RESUABLE IRRIGATION/ASPIRATION HANDPIECEBoston Surgical Products, Inc.1995-02-08
K940392PEREGRINE PIC MINIPULATORPeregrine Surgical , Ltd.1994-08-23
K935003ELECTRIC I/V POLE OR EIVP2Optical Micro Systems, Inc.1994-01-25
K925921MODIFIED SITE DISPOSABLE DIAPHRAGM CASSETTESite Microsurgical Systems, Inc.1993-12-06
K924999AUTOPOLE REGULATOR SYSTEMEscalon Trek Medical1992-12-24
K924052INFINITY MICRO IRRIGATORInfinity Surgical Technology, Inc.1992-12-23

Legacy Summary#

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FDA Review#

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