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510(k) K942233

Device
MKM (MULTIPLE COORDINATE MANIPULATOR) SYSTEM
Applicant
CARL ZEISS, INC.
510(k) number
K942233
Product code
EPT  
Decision
Substantially Equivalent (SESE)
Decision date
1994-07-01
Date received
1994-05-09
Regulation
878.4700
Classification name
Microscope, Surgical
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
CYNTHIA A GIFFORD,RN
Address
One Zeiss Dr. Thornwood NY US 10594 10594

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code EPT  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K931284MICRODYNE OFFICE SURGICAL MICROSCOPEMicrodyne, Inc.1993-11-18
K933310MICRINS CONTRAST BACKGROUND MATERIALMicrins Surgical, Inc.1993-08-19
K903412STORZ MODEL M705 AND/OR M706 CEILING MOUNTED MICR.Storz Instrument Co.1990-09-20
K883581OPMI CSCarl Zeiss, Inc.1988-09-13
K882269STORZ DIAGNOSTIC MICROSCOPE SYSTEMStorz Instrument Co.1988-06-23
K860811ZEISS VOICE CONTROL SYSTEM FOR OPMI'SCarl Zeiss, Inc.1986-04-30
K844858STORZ/URBAN SURGICAL MICROSCOPE SYSTEMStorz Instrument Co.1985-03-25
K832887ELECTRONIC UNITSurgi-Quip Inc.U1983-10-04
K823011VC IIITeknar, Inc.1982-11-08
K822561MICROSCOPETreace Medical, Inc.1982-09-14
K822014NAGASHIMA SU-A CEILING MOUNT UNIT FORKelleher Corp.1982-08-06
K822009BINOCULAR OPERATING MICROSCOPES &Kelleher Corp.1982-07-30
K821689LEBANON MICROSCOPEThe Lebanon Corp.1982-07-09
K812234STORZ/OLYMPUS MICROSCOPE SYSTEMStorz Instrument Co.1981-09-11
K802904MICROSCOPE MODEL OM-UJedmed Instrument Co.1981-02-04

Legacy Summary#

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FDA Review#

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