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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Biopsy
510(k) Number K851837
Device Name MANAN WESTCOTT NEEDLE
Applicant
MANAN MANUFACTURING CO., INC.
8020 NORTH CENTRAL PARK AVE.
SKOKIE,  IL  60076
Applicant Contact MANFRED MITTERMEIER
Correspondent
MANAN MANUFACTURING CO., INC.
8020 NORTH CENTRAL PARK AVE.
SKOKIE,  IL  60076
Correspondent Contact MANFRED MITTERMEIER
Regulation Number876.1075
Classification Product Code
KNW  
Date Received04/26/1985
Decision Date 05/14/1985
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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