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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Biopsy Needle
510(k) Number K895897
Device Name MANAN PROSTATIC BIOPSY NEEDLE
Applicant
Manan Medical Products, Inc.
2200 Carlson Dr.
Northbrook,  IL  60062
Applicant Contact MANFRED MITTERMEIER
Correspondent
Manan Medical Products, Inc.
2200 Carlson Dr.
Northbrook,  IL  60062
Correspondent Contact MANFRED MITTERMEIER
Regulation Number876.1075
Classification Product Code
FCG  
Date Received10/06/1989
Decision Date 10/18/1989
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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