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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name needle, aspiration and injection, disposable
510(k) Number K863848
Device Name MANAN BREST TUMOR LOCALIZATION 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 Number878.4800
Classification Product Code
GAA  
Date Received09/30/1986
Decision Date 10/14/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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