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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 K852426
Device Name MANAN TROCAR STYLE BIOPSY NEEDLE
Applicant
Manan Manufacturing Co., Inc.
8020 N. Central Park Ave.
Skokie,  IL  60076
Applicant Contact MANFRED MITTERMEIER
Correspondent
Manan Manufacturing Co., Inc.
8020 N. Central Park Ave.
Skokie,  IL  60076
Correspondent Contact MANFRED MITTERMEIER
Regulation Number878.4800
Classification Product Code
GAA  
Date Received06/07/1985
Decision Date 06/27/1985
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
Predetermined Change
Control Plan Authorized		 No
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