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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name laparoscope, gynecologic (and accessories)
510(k) Number K931478
Device Name ZEISS OPMI L STEREO-LAPAROSCOPE
Applicant
CARL ZEISS, INC.
305 COLLEGE RD. EAST
PRINCETON,  NJ  08540
Applicant Contact CHRISTOPHER TALBOT
Correspondent
CARL ZEISS, INC.
305 COLLEGE RD. EAST
PRINCETON,  NJ  08540
Correspondent Contact CHRISTOPHER TALBOT
Regulation Number884.1720
Classification Product Code
HET  
Date Received03/24/1993
Decision Date 09/28/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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