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FDA 510(k) Application Details - K142808
Device Classification Name
Staple, Implantable
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510(K) Number
K142808
Device Name
Staple, Implantable
Applicant
CR BARD INC
100 CROSSINGS BLVD
WARWICK, RI 02886 US
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Contact
Andrew Harrell
Other 510(k) Applications for this Contact
Regulation Number
878.4750
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Classification Product Code
GDW
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More FDA Info for this Product Code
Date Received
09/29/2014
Decision Date
03/09/2015
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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