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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 K844561
Device Name BARD URETEROSCOPIC CYTOLOGY BRUSH
Applicant
C.R. Bard, Inc.
111 Spring St.
Murray Hill,  NJ  07974
Applicant Contact DONALD F GRABARZ
Correspondent
C.R. Bard, Inc.
111 Spring St.
Murray Hill,  NJ  07974
Correspondent Contact DONALD F GRABARZ
Regulation Number876.1500
Classification Product Code
FDX  
Date Received11/21/1984
Decision Date 01/08/1985
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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