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FDA 510(k) Application Details - K021847
Device Classification Name
Kit, Needle, Biopsy
More FDA Info for this Device
510(K) Number
K021847
Device Name
Kit, Needle, Biopsy
Applicant
BIOPSY SCIENCES, LLC
5582 CHALON RD.
YORBA LINDA, CA 92886 US
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Contact
SHARON ROCKWELL
Other 510(k) Applications for this Contact
Regulation Number
876.1075
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Classification Product Code
FCG
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More FDA Info for this Product Code
Date Received
06/05/2002
Decision Date
09/03/2002
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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