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FDA 510(k) Application Details - K153087
Device Classification Name
Suture, Nonabsorbable, Synthetic, Polyethylene
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510(K) Number
K153087
Device Name
Suture, Nonabsorbable, Synthetic, Polyethylene
Applicant
Ivy Sports Medicine, LLC
545 Penobscot Drive
Redwood City, CA 94063 US
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Contact
John Dichiara
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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
10/26/2015
Decision Date
07/14/2016
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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