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FDA 510(k) Application Details - K113744
Device Classification Name
Suture, Surgical, Absorbable, Polydioxanone
More FDA Info for this Device
510(K) Number
K113744
Device Name
Suture, Surgical, Absorbable, Polydioxanone
Applicant
ANGIOTECH
100 DENNIS DRIVE
READING, PA 19606 US
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Contact
KIRSTEN STOWELL
Other 510(k) Applications for this Contact
Regulation Number
878.4840
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Classification Product Code
NEW
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More FDA Info for this Product Code
Date Received
12/20/2011
Decision Date
02/01/2012
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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