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FDA 510(k) Application Details - K170957
Device Classification Name
Suture, Nonabsorbable, Synthetic, Polyethylene
More FDA Info for this Device
510(K) Number
K170957
Device Name
Suture, Nonabsorbable, Synthetic, Polyethylene
Applicant
AlloSource
6278 S Troy Circle
Centennial, CO 80111 US
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Contact
Pamela Vetter
Other 510(k) Applications for this Contact
Regulation Number
878.5000
More FDA Info for this Regulation Number
Classification Product Code
GAT
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/31/2017
Decision Date
03/20/2018
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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