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FDA 510(k) Application Details - K191361
Device Classification Name
Suture, Surgical, Absorbable, Polydioxanone
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510(K) Number
K191361
Device Name
Suture, Surgical, Absorbable, Polydioxanone
Applicant
DemeTECH Corporation
14175 NW 60th Ave
Miami Lakes, FL 33014 US
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Contact
Tracy Chadwrick
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Regulation Number
878.4840
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Classification Product Code
NEW
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More FDA Info for this Product Code
Date Received
05/21/2019
Decision Date
11/07/2019
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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