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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, Reusable
510(k) Number K902177
Device Name MANAN BONE 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 Number878.4800
Classification Product Code
GDM  
Date Received05/15/1990
Decision Date 09/05/1990
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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