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EPT — Microscope, Surgical Class I

FDA Device Classification

Classification Details

Product Code
EPT
Device Class
Class I
Regulation Number
878.4700
Submission Type
Review Panel
SU
Medical Specialty
General, Plastic Surgery
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K942233carl zeissMKM (MULTIPLE COORDINATE MANIPULATOR) SYSTEMJuly 1, 1994
K931284microdyneMICRODYNE OFFICE SURGICAL MICROSCOPENovember 18, 1993
K933310micrins surgicalMICRINS CONTRAST BACKGROUND MATERIALAugust 19, 1993
K903412storz instrumentSTORZ MODEL M705 AND/OR M706 CEILING MOUNTED MICR.September 20, 1990
K883581carl zeissOPMI CSSeptember 13, 1988
K882269storz instrumentSTORZ DIAGNOSTIC MICROSCOPE SYSTEMJune 23, 1988
K860811carl zeissZEISS VOICE CONTROL SYSTEM FOR OPMI'SApril 30, 1986
K844858storz instrumentSTORZ/URBAN SURGICAL MICROSCOPE SYSTEMMarch 25, 1985
K832887surgi-quip inc.uELECTRONIC UNITOctober 4, 1983
K823011teknarVC IIINovember 8, 1982
K822561treace medicalMICROSCOPESeptember 14, 1982
K822014kelleherNAGASHIMA SU-A CEILING MOUNT UNIT FORAugust 6, 1982
K822009kelleherBINOCULAR OPERATING MICROSCOPES &July 30, 1982
K821689lebanonLEBANON MICROSCOPEJuly 9, 1982
K812234storz instrumentSTORZ/OLYMPUS MICROSCOPE SYSTEMSeptember 11, 1981
K802904jedmed instrumentMICROSCOPE MODEL OM-UFebruary 4, 1981
K802903jedmed instrumentMICROSCOPE MODEL OM-PFebruary 4, 1981
K760696alcon laboratoriesREMOTE CONTROL SYSTEM FOR MICROSCOPEDecember 16, 1976