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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name General Surgery Tray
510(k) Number K941846
Device Name BONE MARROW BIOPSY TRAY
Applicant
Kormed, Inc.
4445 W. 777th St.
Suite 240
Edina,  MN  55435
Applicant Contact STEPHEN NORDSTED
Correspondent
Kormed, Inc.
4445 W. 777th St.
Suite 240
Edina,  MN  55435
Correspondent Contact STEPHEN NORDSTED
Regulation Number878.4370
Classification Product Code
LRO  
Date Received04/14/1994
Decision Date 05/18/1994
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
Predetermined Change
Control Plan Authorized		 No
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