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FDA 510(k) Application Details - K013071
Device Classification Name
Kit, Needle, Biopsy
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510(K) Number
K013071
Device Name
Kit, Needle, Biopsy
Applicant
H.S. HOSPITAL SERVICES S.P.A.
10147 UMBERLAND PLACE
BOCA RATON, FL 33428 US
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Contact
LUCIO IMPROTA
Other 510(k) Applications for this Contact
Regulation Number
876.1075
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Classification Product Code
FCG
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/13/2001
Decision Date
12/12/2001
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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