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510(k) K920641

Device
ALCON OPERATING MICROSCOPES
Applicant
ALCON LABORATORIES
510(k) number
K920641
Product code
HRM  
Decision
Substantially Equivalent (SESE)
Decision date
1992-10-09
Date received
1992-02-12
Regulation
878.4700
Classification name
Microscope, Operating & Accessories, Ac-powered, Ophthalmic
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
DAVID KRAPF
Address
6201 S. Fwy. R7-14 Fort Worth TX US 76134 76134

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HRM  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K932720HM-0970Hill-Med, Inc.1993-09-07
K930439MARCO SURGISCOPE OPERATION MICROSCOPESMarco Ophthalmic, Inc.1993-07-22
K914956KEELER KONAN SPECULAR MICROSCOPE SP5500Keeler Instruments, Inc.1992-02-03
K891584S 22 INSTRUMENT STANDCarl Zeiss, Inc.1989-06-08
K891001MICROSCOPE KNOB COVER, STERILE, DISPOSABLEPrescott'S, Inc.1989-04-11
K854440MODIFIED CLINICAL WIDEFIELD SPECULAR MICROSCOPE 50Keeler Instruments, Inc.1985-12-16
K853855XTAL X-150 OPERATING MICROSCOPEXtal Corp.1985-10-15
K852586CROMIC SURGICAL MICROSCOPE MODEL MC-1Seltrex, Corp.1985-07-30
K852150CLINICAL WIDEFIELD SPECULAR MICRISCOPE 500Keeler Instruments, Inc.1985-06-03
K850270CORNEAL LIGHT SHIELDMentor O & O, Inc.1985-05-31
K844323KONAN CLINIC MICROSCOPE CLM-100-150Keeler Instruments, Inc.1984-11-21
K822563OPHTHALMIC MICROSCOPETreace Medical, Inc.1982-09-14
K792083HAAG-STREIT SLIT LAMP 900Lumenis, Inc.1979-11-16

Legacy Summary#

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FDA Review#

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