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FDA 510(k) Application Details - K190777
Device Classification Name
Suture, Nonabsorbable, Synthetic, Polyethylene
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510(K) Number
K190777
Device Name
Suture, Nonabsorbable, Synthetic, Polyethylene
Applicant
DemeTECH Corporation
14175 NW 60th Ave
Miami Lakes, FL 33014 US
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Contact
Tracy Chadwrick
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
03/26/2019
Decision Date
07/31/2019
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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