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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 K925968
Device Name ENDOSCOPE
Applicant
United States Surgical, A Division Of Tyco Healthc
150 Glover Ave.
Norwalk,  CT  06856
Applicant Contact CURTIS RAYMOND
Correspondent
United States Surgical, A Division Of Tyco Healthc
150 Glover Ave.
Norwalk,  CT  06856
Correspondent Contact CURTIS RAYMOND
Regulation Number884.1720
Classification Product Code
HET  
Date Received11/25/1992
Decision Date 04/28/1994
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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