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FDA 510(k) Application Details - K212146
Device Classification Name
Suture, Nonabsorbable, Synthetic, Polyethylene
More FDA Info for this Device
510(K) Number
K212146
Device Name
Suture, Nonabsorbable, Synthetic, Polyethylene
Applicant
Arthrex, Inc.
1370 Creekside Boulevard
Naples, FL 34108 US
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Contact
Lai Saeteurn
Other 510(k) Applications for this Contact
Regulation Number
878.5000
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Classification Product Code
GAT
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More FDA Info for this Product Code
Date Received
07/09/2021
Decision Date
10/25/2021
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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