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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Microscope, Surgical
510(k) Number K931284
Device Name MICRODYNE OFFICE SURGICAL MICROSCOPE
Applicant
Microdyne, Inc.
13948 Oakwood Glen Pl.
Valley Center,  CA  92082
Applicant Contact DOUG HEGE
Correspondent
Microdyne, Inc.
13948 Oakwood Glen Pl.
Valley Center,  CA  92082
Correspondent Contact DOUG HEGE
Regulation Number878.4700
Classification Product Code
EPT  
Date Received02/11/1993
Decision Date 11/18/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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