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FDA 510(k) Application Details - K964777
Device Classification Name
Instrument, Biopsy
More FDA Info for this Device
510(K) Number
K964777
Device Name
Instrument, Biopsy
Applicant
GALLINI INTL., INC.
3106 BRETTON COURT
GLEN ALLEN, VA 23060 US
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Contact
PAUL L HAWTHORNE
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
11/27/1996
Decision Date
01/03/1997
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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