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FDA 510(k) Application Details - K142656
Device Classification Name
Suture, Absorbable, Natural
More FDA Info for this Device
510(K) Number
K142656
Device Name
Suture, Absorbable, Natural
Applicant
COVIDIEN
60 MIDDLETOWN AVE.
NORTH HAVEN, CT 06473 US
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Contact
Mary Mellows
Other 510(k) Applications for this Contact
Regulation Number
878.4830
More FDA Info for this Regulation Number
Classification Product Code
GAL
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/18/2014
Decision Date
01/29/2015
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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