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FDA 510(k) Application Details - K193575
Device Classification Name
Suture, Nonabsorbable, Synthetic, Polyethylene
More FDA Info for this Device
510(K) Number
K193575
Device Name
Suture, Nonabsorbable, Synthetic, Polyethylene
Applicant
Arthrex Inc.
1370 Creekside Boulevard
Naples, FL 34108-1945 US
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Contact
Ivette Galmez
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
12/23/2019
Decision Date
07/24/2020
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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