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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hysteroscope (And Accessories)
510(k) Number K003802
Device Name HYSTEROSCOPES
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 Number884.1690
Classification Product Code
HIH  
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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