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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Coagulator, Culdoscopic (And Accessories)
510(k) Number K925114
Device Name LAPAROSCOPIC INSTRUMENTS
Applicant
Endo Technic Corp.
3027 Commerical Ave.
Northbrook,  IL  60062
Applicant Contact DAM GUDEMAN
Correspondent
Endo Technic Corp.
3027 Commerical Ave.
Northbrook,  IL  60062
Correspondent Contact DAM GUDEMAN
Regulation Number884.4160
Classification Product Code
HFI  
Date Received10/09/1992
Decision Date 02/28/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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