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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 K000197
Device Name CORTEK CYSTOSCOPE
Applicant
Cortek Endoscopy, Inc.
501 W. Colfax, Suite B
Palatine,  IL  60067
Applicant Contact CORNEL M TOPALA
Correspondent
Cortek Endoscopy, Inc.
501 W. Colfax, Suite B
Palatine,  IL  60067
Correspondent Contact CORNEL M TOPALA
Regulation Number876.1500
Classification Product Code
FAJ  
Date Received01/21/2000
Decision Date 03/03/2000
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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