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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 K852897
Device Name LEE BONE MARROW BIOPSY/ASPIRATION TRAY
Applicant
Southland Instruments, Inc.
P.O. Box 24288
Minneapolis,  MN  55424
Applicant Contact EDWARD N LEE
Correspondent
Southland Instruments, Inc.
P.O. Box 24288
Minneapolis,  MN  55424
Correspondent Contact EDWARD N LEE
Regulation Number878.4800
Classification Product Code
GAA  
Date Received07/09/1985
Decision Date 08/21/1985
Decision Substantially Equivalent - With Drug (SESD)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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