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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tray, Biopsy, Without Biopsy Instruments
510(k) Number K852105
Device Name MANAN UBK ULTRASONIC GUIDED BIOPSY KIT
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 Number876.4730
Classification Product Code
FCH  
Date Received05/15/1985
Decision Date 06/18/1985
Decision Substantially Equivalent - With Drug (SESD)
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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