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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name powered laser surgical instrument
510(k) Number K013402
Device Name VISULAS 532S
Applicant
CARL ZEISS, INC.
ONE ZEISS DR.
THORNWOOD,  NY  10594
Applicant Contact KENNETH M NICOLL
Correspondent
CARL ZEISS, INC.
ONE ZEISS DR.
THORNWOOD,  NY  10594
Correspondent Contact KENNETH M NICOLL
Regulation Number878.4810
Classification Product Code
GEX  
Date Received10/15/2001
Decision Date 11/14/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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