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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Biopsy
510(k) Number K010037
Device Name DAUM DOUBLE-SHOOT BISOPSY GUN
Applicant
Daum GmbH
P.O. Box 4341
Crofton,  MD  21114
Applicant Contact CHRISTINA SMITH
Correspondent
Daum GmbH
P.O. Box 4341
Crofton,  MD  21114
Correspondent Contact CHRISTINA SMITH
Regulation Number876.1075
Classification Product Code
KNW  
Date Received01/04/2001
Decision Date 03/22/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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