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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, general & plastic surgery
510(k) Number K874241
Device Name OPMI MD SURGICAL MICROSCOPE
Applicant
CARL ZEISS, INC.
ONE ZEISS DR.
THORNWOOD,  NY  10594
Applicant Contact VAN CADER
Correspondent
CARL ZEISS, INC.
ONE ZEISS DR.
THORNWOOD,  NY  10594
Correspondent Contact VAN CADER
Regulation Number878.4700
Classification Product Code
FSO  
Date Received10/15/1987
Decision Date 12/23/1987
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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