FDA 510(k) Application Details - K991366

Device Classification Name Instrument, Biopsy

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510(K) Number K991366
Device Name Instrument, Biopsy
Applicant DAUM GMBH
P.O. BOX 4341
CROFTON, MD 21114 US
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Contact E.J. Smith
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Regulation Number 876.1075

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Classification Product Code KNW
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Date Received 04/20/1999
Decision Date 06/25/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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