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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 K860811
Device Name ZEISS VOICE CONTROL SYSTEM FOR OPMI'S
Applicant
CARL ZEISS, INC.
ONE ZEISS DR.
THORNWOOD,  NY  10594
Applicant Contact MARIE PEDERSON
Correspondent
CARL ZEISS, INC.
ONE ZEISS DR.
THORNWOOD,  NY  10594
Correspondent Contact MARIE PEDERSON
Regulation Number878.4700
Classification Product Code
EPT  
Date Received03/04/1986
Decision Date 04/30/1986
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
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