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FDA 510(k) Application Details - K220186
Device Classification Name
Suture, Nonabsorbable, Synthetic, Polyethylene
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510(K) Number
K220186
Device Name
Suture, Nonabsorbable, Synthetic, Polyethylene
Applicant
CONMED Corporation
525 French Road
Utica, NY 13502 US
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Contact
Orjada Dervishleri
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
01/24/2022
Decision Date
05/13/2022
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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