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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 K925079
Device Name LAPAROSCOPIC INST. (SCISSORS,FORCEPS,NEEDLEHOLDER)
Applicant
ENDO TECHNIC CORP.
3027 COMMERICAL AVE.
NORTHBROOK,  IL  60062
Applicant Contact DAN GUDEMAN
Correspondent
ENDO TECHNIC CORP.
3027 COMMERICAL AVE.
NORTHBROOK,  IL  60062
Correspondent Contact DAN GUDEMAN
Regulation Number884.1720
Classification Product Code
HET  
Date Received10/07/1992
Decision Date 08/24/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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