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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 K003803
Device Name GENERAL SURGICAL LAPAROSCOPES
Applicant
GLOBAL ENDOSCOPY, INC.
914 W. ESTES CT.
SCHAUMBURG,  IL  60193 -4426
Applicant Contact NICK MIRCEA
Correspondent
GLOBAL ENDOSCOPY, INC.
914 W. ESTES CT.
SCHAUMBURG,  IL  60193 -4426
Correspondent Contact NICK MIRCEA
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received12/08/2000
Decision Date 03/07/2001
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
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