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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K950985
Device Name ZEISS ENDOLIVE STERO ENDOSCOPE
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 Number876.1500
Classification Product Code
GCJ  
Date Received03/03/1995
Decision Date 03/29/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
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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