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FDA 510(k) Application Details - K222078
Device Classification Name
Suture, Nonabsorbable, Synthetic, Polyethylene
More FDA Info for this Device
510(K) Number
K222078
Device Name
Suture, Nonabsorbable, Synthetic, Polyethylene
Applicant
Arthrex, Inc
1370 Creekside Boulevard
Naples, FL 34108-1945 US
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Contact
Kelsey Roberts
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
07/14/2022
Decision Date
09/14/2022
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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