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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Cytology Brush
510(k) Number K914504
Device Name CYTOLOGY BRUSH
Applicant
Surgitek Medical Engineering Corp.
3037 Mt. Pleasant St.
Racine,  WI  53404
Applicant Contact BRIAN KUNST
Correspondent
Surgitek Medical Engineering Corp.
3037 Mt. Pleasant St.
Racine,  WI  53404
Correspondent Contact BRIAN KUNST
Regulation Number876.1500
Classification Product Code
FDX  
Date Received10/09/1991
Decision Date 02/18/1992
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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