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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Light Source, Endoscope, Xenon Arc
510(k) Number K936198
Device Name ZEISS SUPERLUX HIGH-INTENSITY LIGHT SOURCES
Applicant
Carl Zeiss, Inc.
One Zeiss Dr.
Thornwood,  NY  10594
Applicant Contact CYNTHIA A GIFFORD, RN
Correspondent
Carl Zeiss, Inc.
One Zeiss Dr.
Thornwood,  NY  10594
Correspondent Contact CYNTHIA A GIFFORD, RN
Regulation Number876.1500
Classification Product Code
GCT  
Date Received12/29/1993
Decision Date 04/06/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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