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FDA 510(k) Application Details - K171589
Device Classification Name
Staple, Implantable
More FDA Info for this Device
510(K) Number
K171589
Device Name
Staple, Implantable
Applicant
Lexington Medical Inc.
11 Executive Park Dr.
Billerica, MA 01862 US
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Contact
Donna Gasper
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
05/31/2017
Decision Date
11/17/2017
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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