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FDA 510(k) Application Details - K981320
Device Classification Name
Instrument, Biopsy
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510(K) Number
K981320
Device Name
Instrument, Biopsy
Applicant
DAUM CORP.
9645 WEHRLE DR.
CLARENCE, NY 14031 US
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Contact
GARY J SFEIR, RAC
Other 510(k) Applications for this Contact
Regulation Number
876.1075
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Classification Product Code
KNW
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More FDA Info for this Product Code
Date Received
04/10/1998
Decision Date
06/29/1998
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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