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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 K990278
Device Name DAUM NEUROCUT NEUROBIOPSYNEEDLE
Applicant
Daum Corp.
P.O. Box 4341
Crofton,  MD  21114
Applicant Contact E.J. Smith
Correspondent
Daum Corp.
P.O. Box 4341
Crofton,  MD  21114
Correspondent Contact E.J. Smith
Regulation Number876.1075
Classification Product Code
KNW  
Date Received01/28/1999
Decision Date 03/30/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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