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FDA 510(k) Application Details - K173335
Device Classification Name
Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene
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510(K) Number
K173335
Device Name
Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene
Applicant
Dura Tap LLC
208 Upland Way
Wayne, PA 19087 US
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Contact
Ann R. Lee
Other 510(k) Applications for this Contact
Regulation Number
878.5035
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Classification Product Code
NBY
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More FDA Info for this Product Code
Date Received
10/23/2017
Decision Date
02/08/2018
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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