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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cystoscope And Accessories, Flexible/Rigid
510(k) Number K003807
Device Name CYSTOSCOPES
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 Number876.1500
Classification Product Code
FAJ  
Date Received12/08/2000
Decision Date 02/22/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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