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FDA 510(k) Application Details - K150891
Device Classification Name
Kit, Needle, Biopsy
More FDA Info for this Device
510(K) Number
K150891
Device Name
Kit, Needle, Biopsy
Applicant
Covidien LLC( Formerly Beacon Endoscopic Corp.)
15 Hamshire Street
Mansfield, MA 02048 US
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Contact
Saket Bhatt
Other 510(k) Applications for this Contact
Regulation Number
876.1075
More FDA Info for this Regulation Number
Classification Product Code
FCG
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/02/2015
Decision Date
05/01/2015
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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