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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 K912074
Device Name BONE MARROW BIOPSY TRAY
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
GAA  
Date Received05/10/1991
Decision Date 08/28/1991
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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