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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 K791668
Device Name ENDOSCOPIC CYTOLOGY BRUSHES
Applicant
Mill-Rose Laboratory
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Mill-Rose Laboratory
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number876.1500
Classification Product Code
FDX  
Date Received08/28/1979
Decision Date 10/01/1979
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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