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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 K944044
Device Name CHIBA STYLE BIOPSY NEEDLE
Applicant
Kormed, Inc.
4445 W. 777th St.
Suite 240
Edina,  MN  55435
Applicant Contact STEPHEN NORSTED
Correspondent
Kormed, Inc.
4445 W. 777th St.
Suite 240
Edina,  MN  55435
Correspondent Contact STEPHEN NORSTED
Regulation Number878.4370
Classification Product Code
LRO  
Date Received08/18/1994
Decision Date 10/03/1994
Decision Substantially Equivalent - Kit With Drugs (SEKD)
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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