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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 K842106
Device Name LEE BONE MARROW NEEDLES
Applicant
SOUTHLAND INSTRUMENTS, INC.
P.O. BOX 24288
MINNEAPOLIS,  MN  55424
Applicant Contact PETER F LEE
Correspondent
SOUTHLAND INSTRUMENTS, INC.
P.O. BOX 24288
MINNEAPOLIS,  MN  55424
Correspondent Contact PETER F LEE
Regulation Number878.4800
Classification Product Code
GAA  
Date Received05/25/1984
Decision Date 08/10/1984
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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