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510(k) K913239

Device
GOLDLENS(TM)
Applicant
DORAN INSTRUMENTS, INC.
510(k) number
K913239
Product code
HLZ  
Decision
Substantially Equivalent (SESE)
Decision date
1992-01-31
Date received
1991-07-22
Regulation
886.1220
Classification name
Electrode, Corneal
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
BRUCE DORAN
Address
410 Great Rd. P.O. Box 1070 Littleton MA US 01460 01460

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HLZ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K253586RM Electrode (RMH 25-01)Retmap, Inc.2026-04-01
K232273RM Electrode (RMH 23-01)Retmap, Inc.2023-12-07
K961805TOMEY DTL ELECTRODETomey Corporation USA1997-05-09
K926540SOPHER AND BIERER OVUM FORCEPSThomasville Medical Assoc.1994-02-25
K844409DTL ELECTRODESauquoit Industries, Inc.1985-02-14
K830557ERG-JET ELECTRODEUniverso S.A.1983-03-31
K820254GOLD FOIL ERG ELECTRODESCadwell Laboratories, Inc.1982-04-09
K813399ERG-JET ELECTRODENicolet Biomedical Instruments1982-01-22
K781476MULAR GOLD LEAF ELECTRODE MODEL 7501Life-Tech Instruments, Inc.1978-11-15
K760199ELECTRORETINOGRAPHLkc Technologies, Inc.1976-08-04

Legacy Summary#

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FDA Review#

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