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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 K003805
Device Name GYNECOLOGICAL LAPAROSCOPES
Applicant
Global Endoscopy, Inc.
914 W. Estes Ct.
Schaumburg,  IL  60193
Applicant Contact NICK MIRCEA
Correspondent
Global Endoscopy, Inc.
914 W. Estes Ct.
Schaumburg,  IL  60193
Correspondent Contact NICK MIRCEA
Regulation Number884.1720
Classification Product Code
HET  
Date Received12/08/2000
Decision Date 07/22/2001
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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