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510(k) K912522

Device
Omniview(tm) Ophthalmic Fiberendo W/needleholder
Applicant
SUMMIT TECHNOLOGY, INC.
510(k) number
K912522
Product code
EQH
Decision
Substantially Equivalent (SESE)
Decision date
1991-07-25
Date received
1991-05-22
Regulation
874.4350
Classification name
Source, Carrier, Fiberoptic Light
Medical specialty
Ear, Nose, Throat
Review panel
Ear, Nose, Throat
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
KIMBERLEY DONEY
Address
21 Hickory Dr. Waltham MA US 02154 02154

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code EQH#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K945876WECO ENDOSCOPIC SYSTEM WITH FIBER OPTIC LIGHTWells Johnson Co.1995-12-04
K954184JED-LIGHT FIBEROPTIC LIGHT SOURCEJedmed Instrument Co.1995-11-13
K951829COLD LIGHT SOURCE LOS 150Laser-Optik-Systeme GmbH & Co. KG1995-07-10
K932771BATTERY POWERED, DISPOSABLE ENDOSCOPE LIGHT SOURCEXomed-Treace, Inc.1994-08-24
K941661GM OPTI*CAM CAMER WITH DENTAL FIBER OPTIC LIGHTGm Engineering, Inc.1994-08-23
K941662GM OPTI*CAM CAMERA WITH ENT FIBER OPTIC LIGHTGm Engineering, Inc.1994-07-20
K934911SAPHIRE PLUS SURGICAL MIRRORSan Diego Swiss Machining, Inc.1994-06-21
K932131MID LABS TWIN ILLUMINATORMedical Instrument Development Laboratories, Inc.1994-04-01
K930123ASPIRATING ENDO OCULAR PROBESurgical Technologies, Inc.1994-02-16
K933145FIBEROPTIC LIGHTSOURCES AND CARRIERSElectro Fiberoptics Corp.1993-09-07
K923227THROAT-A-SCOPETruphatek, Ltd.1992-12-04
K923774DISPOSABLE ENDOILLUMINATORO.R. Specialties, Inc.1992-10-19
K922095LX 150 LIGHT SOURCEWelch Allyn, Inc.1992-07-17
K914586GRIESHABER THREE FUNCTION MANIPULATORGrieshaber & Co.1992-01-03
K914585GRIESHABER TWO FUNCTION MANIPULATORGrieshaber & Co.1992-01-03