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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 K000199
Device Name CORTEK MINI LAPAROSCOPE
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 Number884.1720
Classification Product Code
HET  
Date Received01/21/2000
Decision Date 04/13/2000
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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